AzTrials
AzTrials

AdenocarcinomaPhase 3NCT07385703

Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.

A Phase 3 study testing LM-302 Injection, Tislelizumab and Oxaliplatin Injection in people with Adenocarcinoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 106 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients with CLDN18.2 positivity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma
What is being tested?
LM-302 Injection, Tislelizumab and Oxaliplatin Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
752 participants
Where
106 sitesChina
Study dates
15 Apr 2026to May 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to comply with the study's visit schedule, treatment plan, laboratory tests, and other research procedures.
  • Age ≥ 18 years.
  • Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
  • For locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has not previously received any systemic treatment:
  • Patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on a platinum-based combination chemotherapy regimen and have not developed distant metastasis or local recurrence within 6 months after completion of treatment can be included.
  • The calculation of a 6-month interval is defined as recurrence within the same date range after 6 months. For example, if the end date of the last treatment is January 1, the 6-month period from that date refers to January 1 to July 1 (including July 1). Alternatively, if the end date of the last treatment is August 31, the 6-month period from that date refers to August 31 to February 28 (or February 29 in leap years).
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  • Archived specimens or fresh tumor tissue specimens from ≤3 years ago must be provided for CLDN18.2 and PD-L1 testing (PD-L1 results are not a condition for enrollment). When multiple samples are present, the most recent accessible and qualified sample must be provided. After confirmation by the central laboratory, tumor tissue with positive CLDN18.2 expression is defined as ≥25% tumor cell membrane staining intensity 2+ \& 3+. For patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on platinum-containing combination chemotherapy regimens, newly obtained tissue from recurrent or metastatic lesions must be provided for CLDN18.2 and PD-L1 testing.
  • A negative report on the expression detection of human epidermal growth factor receptor-2 (HER2) in tumor tissue must be provided. The definition of HER2 negative expression is ImmunoHistoChemistry (IHC) score 0/1+, IHC score 2+, and fluorescence in situ hybridization (FISH) negative.
  • According to the RECIST 1.1 evaluation criteria, there must be at least one measurable lesion.
  • Expected survival duration ≥ 3 months.
  • According to the Eastern Cooperative Oncology Group (ECOG) standards, the physical performance status score is 0 or 1.
  • Good organ function: a. Bone marrow reserve: Platelets (PLT) ≥ 100×10^9/L, absolute neutrophil count (ANC) ≥ 1.5×10^9/L, Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or supportive treatment such as colony-stimulating factors within 14 days prior to hematology parameter examination during the screening period); b. Coagulation function: International normalized ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5×upper limit of normal (ULN); c. Liver function: Total bilirubin ≤ 1.5×ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤ 2.5×ULN (if there is liver metastasis, then ALT and AST ≤ 5×ULN) and Albumin (ALB) ≥ 30 g/L; d. Renal function: Creatinine clearance rate ≥ 50 mL/min (calculated according to the Cockcroft-Gault formula); e. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; QT interval (QTcF) ≤ 470 ms for females and ≤ 450 ms for males.
  • Women of childbearing age must have a negative blood pregnancy test within 7 days before administration; any fertile male and female subjects must agree to use highly effective contraception throughout the study medication period and for 7 months after the last dose of the study. Males must agree to refrain from donating sperm during the study period and for 7 months after the last dose of the study. Females must agree to refrain from breastfeeding during the study period.

Who cannot join

  • Other pathological types confirmed by histopathology, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.
  • There are gastric cancer lesions confirmed by imaging that are accompanied by cavities or necrosis, and are closely related to major blood vessels, and are assessed by the researchers as posing a high risk of major bleeding.
  • Patients with known central nervous system (CNS) metastases. Patients with non-meningeal, midbrain, pontine, or spinal cord metastases who are judged by the investigator to have stable brain metastases can be enrolled. Stable brain metastases are defined as patients whose brain metastases have undergone treatment and the condition of the metastases has stabilized (brain imaging examination at least 28 days before randomization shows stable lesions, no neurological symptoms, and no immediate need for local or systemic treatment within 14 days before randomization), with no evidence of new or previously existing brain metastases enlarging.
  • Clinically uncontrollable third-space effusion, such as moderate or greater volume, requiring long-term catheterization, previous history of intestinal obstruction or paralysis, compartmented ascites, undergoing or planning to undergo local treatment (including drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy) within 14 days prior to screening, or significant increase within 2 weeks after local treatment, meeting any of the above criteria or deemed unsuitable for enrollment by the investigator.
  • Patients with symptomatic spinal cord compression, or those who are expected to develop symptoms of spinal cord compression if left untreated; or for patients with previously diagnosed and treated spinal cord compression, there is no evidence indicating that the disease was clinically stable for ≥4 weeks before the first study drug administration; except for patients with asymptomatic spinal cord compression indicated by imaging, who are assessed as stable by a specialist and do not require treatment for spinal cord compression at this time.
  • Accompanied by severe peritoneal metastasis, the main manifestations are: clinically significant intestinal obstruction; barium enema indicating small intestinal stenosis.
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  • History of gastrointestinal perforation or gastrointestinal fistula within the previous 6 months. If the perforation or fistula has been treated through resection or repair surgery, and the condition is assessed by the investigator as having been cured or controlled, participation in the study is permissible.
  • Poorly controlled tumor-related pain:
  • For patients requiring analgesic treatment, a stable dosage of treatment must be established before participating in the study.
  • Symptomatic lesions suitable for palliative radiotherapy (such as bone metastasis or metastasis causing nerve damage) should be treated before enrollment.
  • Before enrollment, if appropriate, consideration should be given to local treatment for asymptomatic metastatic lesions that may lead to functional deficits or intractable pain due to further growth (e.g., epidural metastasis not currently associated with spinal cord compression).
  • Patients with a body weight of less than 35kg or a body weight loss of more than 10% within 2 months prior to signing the informed consent form.
  • Exclusion criteria for comorbidities or concomitant conditions:
  • History of malignancy other than Gastric Cancer (GC)/GastroEsophageal Junction adenocarcinoma (GEJ) adenocarcinoma within 2 years prior to randomization, with the following exceptions: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, squamous cell carcinoma of the skin, etc., which have been completely cured and treated.
  • History of autoimmune diseases, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following conditions are excluded: • Subjects with autoimmune-related hypothyroidism who are receiving stable-dose thyroid hormone replacement therapy.
  • Subjects with type 1 diabetes who are well-controlled under a stable insulin treatment regimen.
  • Only subjects with skin autoimmune diseases that do not require systemic treatment (such as vitiligo, alopecia, psoriasis, or eczema).
  • Subjects who have recovered from childhood asthma and do not require any intervention in adulthood.
  • Subjects whose relevant diseases, as assessed by the researchers, are unlikely to recur without external triggers.
  • Patients who have previously undergone allogeneic bone marrow transplantation or solid organ transplantation.
  • Patients with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, left bundle branch block, prolonged QRS complex, etc.;
  • Patients with thromboembolic events requiring therapeutic anticoagulation, or those with venous filters;
  • Patients with heart failure of New York Heart Association (NYHA) class III or IV;
  • Patients who have experienced acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular and cerebrovascular events of grade 3 or above within the previous 6 months prior to randomization.
  • Have a history of myocarditis or cardiomyopathy.
  • For individuals infected with human immunodeficiency virus (HIV) and those with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the following conditions are allowed for enrollment: • Patients who are HBsAg positive, with or without HBcAb positivity, and have HBV DNA < 500 IU/mL or below the lower limit of the reference value set by the research center, and who, based on clinical treatment, manifestations, and other factors, are judged by the investigator to have no active infection; • Patients who are HCV antibody positive but HCV RNA negative.
  • Subjects with known active syphilis infection.
  • Individuals who are unable to control themselves or have severe illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks before the first dose, and interstitial pneumonia/lung disease requiring intervention during screening.
  • Subjects with known active tuberculosis. For patients suspected of having active tuberculosis, a comprehensive evaluation should be conducted based on chest imaging, sputum smear/culture, or molecular testing results, as well as clinical symptoms and signs, to make a definitive diagnosis.
  • Currently present peripheral sensory or motor neuropathy of ≥ grade 2.
  • Subjects who received systemic corticosteroids (>10mg/d prednisone equivalent) or other systemic immunosuppressants (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs [anti-Tumor Necrosis Factor (TNF)] within 2 weeks prior to the first study drug administration.
  • Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed;
  • Patients receiving acute low-dose systemic immunosuppressive drugs (e.g., single-dose dexamethasone for nausea);
  • Patients requiring baseline and subsequent MRI/CT tumor assessments who have previously experienced allergic reactions to intravenous contrast agents may receive prophylactic steroids;
  • Inhaled corticosteroids are allowed for the treatment of chronic obstructive pulmonary disease, hydrocortisone for the treatment of orthostatic hypotension, and low-dose corticosteroid hormone maintenance therapy for adrenal insufficiency.
  • There are factors that affect the application and absorption of oral medications, such as dysphagia, clinically uncontrollable persistent and recurrent vomiting (such as caused by gastric outlet obstruction), intestinal obstruction, and chronic diarrhea. 21. Within 28 days before randomization, there was uncontrollable/severe gastrointestinal bleeding, active peptic ulcer, or active gastrointestinal inflammation/infectious diseases (such as active diverticulitis, abdominal abscess). Subjects who have not undergone radical surgical resection of the primary lesion must undergo fecal occult blood testing before enrollment. If the result is positive, further evaluation, including but not limited to gastroscopy, is required before medication administration to confirm the presence of active bleeding from the lesion and assess the risk of bleeding.
  • The adverse reactions from previous anti-tumor treatment within the 14 days prior to randomization have not yet recovered to a level of ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grading system (excluding toxicities that the investigator deems to pose no safety risk, are asymptomatic, or are controllable with stable medication, such as hair loss, long-term toxicity caused by radiotherapy, and other toxicities that are ≤ grade 2).
  • Have a history of allergy to LM-302, Ticagrelor, any control drug, or its excipients.
  • Individuals with known mental illnesses or disorders that may affect trial compliance.
  • Within 28 days prior to randomization, the subject is currently participating or has previously participated in any investigational drug study, or has used an investigational device within 28 days. Subjects who have entered the follow-up period of an investigational drug study and have not used the investigational drug for ≥28 days since the last use may meet the inclusion criteria for this study.
  • Previously received targeted therapy targeting CLDN18.2, such as antibody-drug conjugate (ADC) therapy, antibody therapy, and chimeric antigen receptor T-cell (CAR-T) therapy; previously received ADC therapy using small molecule toxin Monomethyl auristatin E (MMAE).
  • Subjects who have received palliative local treatment (such as radiotherapy or surgery) for non-target lesions within 2 weeks prior to the first dose, or who have previously received radiotherapy for locally advanced unresectable or metastatic gastric cancer or GEJ adenocarcinoma and have not recovered from toxicity within 2 weeks prior to randomization.
  • Within the first 2 weeks before randomization, patients received systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications, or with Chinese herbal medicine, or with drugs with immune regulatory effects (including thymosin, interferon, interleukin, etc.).
  • Having undergone or planning to undergo major surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within the 28 days prior to randomization or during the study period.
  • Use of strong inhibitors/strong inducers of CYP3A4 within 14 days before randomization;
  • Vaccination with any live vaccine or attenuated live vaccine within 28 days before randomization.
  • Other situations where the researcher deems it inappropriate for participation in this study.

Trial locations and contacts

106 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lin Shen, Doctor contact

13911219511

dctorshenlin@sina.cn

Jin Li, Doctor contact

13761222111

lijin@csco.org.cn

106 sites in 1 country

China106 sites, 106 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan, 455000

    Jin Xia, Doctor, 15890750990, 15890750990@126.com

    Not yet recruiting

  • Baoji Central Hospital

    Baoji, Shaanxi, 721008

    Yayu Zhao, Doctor, 13649179265, zynzhx@163.com

    Not yet recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Wei Deng, Doctor, 13426136152, dengweiwei@126.com

    Not yet recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, Doctor, 13911219511, dctorshenlin@sina.cn

    Recruiting

  • Beijing Lu He Hospital ,Capital Medical University

    Beijing, Beijing Municipality, 101149

    Dong Yan, Doctor, 13621308215, yd15yt88@163.com

    Not yet recruiting

  • Beijing Gaobo Hospital Co., Ltd.

    Beijing, Beijing Municipality, 102200

    Ming Lu, Doctor, 15801292978, minglupku@126.com

    Not yet recruiting

  • Beijing Tsinghua changgung Hospital

    Beijing, Beijing Municipality, 102218

    Guoxin Li, Doctor, 13802771450, lgxa04510@btch.edu.cn

    Not yet recruiting

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130000

    Enyong Dai, Doctor, 13074305913, 58748854@qq.com

    Not yet recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Haifeng Liu, Master, 15804315542, HFLIU2025@163.com

    Not yet recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130000

    Wei Li, Doctor, 13756661267, jdyylw@163.com

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Zhenyang Liu, Doctor, 18673181133, 18673181133@163.com

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Yi He, Doctor, 18692237222, heyi@hnca.org.cn

    Not yet recruiting

  • Chang zhi People's Hospital

    Changzhi, Shanxi, 046000

    Jun Zhao, Doctor, 13835578500, zhaojun380@163.com

    Not yet recruiting

  • The First People's Hospital Of Changzhou

    Changzhou, Jiangsu, 213000

    Jun Wu, Doctor, 13057144311, wujun68@sina.com

    Not yet recruiting

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, 067000

    Qingshan Li, Master, 15633142750, libing200865@126.com

    Not yet recruiting

  • Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital

    Chengdu, Sichuan, 610000

    Xueqiang Zhu, Master, 18981838387, zhuxueqiang1234@163.com

    Not yet recruiting

  • Sichuan Provincial Cancer Hospital

    Chengdu, Sichuan, 610041

    Yongdong Jin, Doctor, 18908190337, cccjin@163.com

    Not yet recruiting

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610041

    Ming Liu, Doctor, 18980606327, mingliu721@163.com

    Not yet recruiting

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia, 24000

    Minghui Zhang, Master, 18047660525, cfzhangminghui@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    Jun Zhang, Master, 13617666067, zjun2323@sina.cn

    Not yet recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

    Li Zhang, Bachelor, 13983531750, ZH-L003@126.com

    Not yet recruiting

  • Affiliated Zhongshan Hospital Of Dalian University

    Dalian, Liaoning, 116001

    Ruoyu Wang, Doctor, 13942875869, 357122231@qq.com

    Xiang Li, Master, 18018931093, 94207842@qq.com

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

    Rongbo Lin, Bachelor, 13705919382, rongbo_lin@163.com

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

    Jinhuo Lai, Doctor, 13365910028, 571747377@qq.com

    Not yet recruiting

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350000

    Zhenhua Liu, Doctor, 13850118018, liuzhenghua6909@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510030

    Jinsong Chen, Doctor, 15920379816, hychenjs@126.com

    Not yet recruiting

  • Guangdong provincial people's hospital

    Guangzhou, Guangdong, 510080

    Jian Xiao, Doctor, 13711114566, xiaojian@gdph.org.cn

    Not yet recruiting

  • The Sixth Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Lei Lian, Doctor, 15913114265, sabiston@126.com

    Not yet recruiting

  • Guigang City People's Hospital

    Guigang, Guangxi, 537100

    Qijin Pan, Master, 15977584028, 305798802@qq.com

    Not yet recruiting

  • The People's Hospital of Guizhou Province

    Guiyang, Guizhou, 550002

    Shisheng Tan, Doctor, 13809427655, tssh18018@126.com

    Not yet recruiting

  • Hainan general hospital

    Haikou, Hainan, 570311

    Yanjing Haung, Doctor, 13307527827, 13307527827@163.com

    Not yet recruiting

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570311

    Erxia He, Master, 13158980546, heerxia@163.com

    Not yet recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Haizhou Lou, Doctor, 19957173556, Louhz09@163.com

    Not yet recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Jian Ruan, Doctor, 19883156851, Software233@zju.edu.cn

    Not yet recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310017

    Ningjun Yu, Doctor, 15068882349, dcx_1982@163.com

    Not yet recruiting

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

    Tongsen Zheng, Doctor, 15134569619, ztcgcp@126.com

    Not yet recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230000

    Yifu He, Doctor, 18963789042, 834638033@qq.com

    Not yet recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230000

    Shuanghu Yuan, Doctor, 13853106916, Yuanshuanghu@sina.com

    Not yet recruiting

  • Anhui Provincial Hospital (The First Affiliated Hospital of China University of Science and Technology)

    Hefei, Anhui, 230000

    Yubei Sun, Master, 13955195511, 909268434@qq.com

    Not yet recruiting

  • The Second Hospital Of Anhui Medical University

    Hefei, Anhui, 230601

    Mingjun Zhang, Master, 13865952007, mjzhang2010@outlook.com

    Not yet recruiting

  • Peking University Cancer Hospital Inner Mongolia Hospita

    Hohhot, Inner Mongolia, 010000

    Xiaotian Zhang, Doctor, 13810995536, zhangxiaotianmed@163.com

    Not yet recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010000

    Caixia Liu, Master, 18847189559, lcxzhg1974@163.com

    Not yet recruiting

  • Jiamusi Tuberculosis Hospital (Jiamusi Cancer Hospital)

    Jiamusi, Heilongjiang, 154002

    Hongmei Sun, Bachelor, 15344540000, shm1357@163.com

    Not yet recruiting

  • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)

    Jinan, Shandong, 250000

    Zuoxing Niu, Master, 13506413687, nzxsdth@163.com

    Not yet recruiting

  • Jinan Central Hospital (City level)

    Jinan, Shandong, 250000

    Meili Sun, Master, 18953116532, smli1980@163.com

    Not yet recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei, 430000

    Yan Hu, Doctor, 18163137369, helensparkle@163.com

    Not yet recruiting

  • Affiliated Hospital Of Ji Ning Medical University

    Jining, Shandong, 272029

    Junye Wang, Bachelor, 18678766866, jiningwangjunye@163.com

    Lei Han, Master, 18678766981, hanleixxf@126.com

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650000

    Lin Xie, Master, 15368030937, xielinyanghangcp@163.com

    Not yet recruiting

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

    Hui Cai, Doctor, 15117157032, caialon@163.com

    Not yet recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Xiaoming Hou, Doctor, 13609366286, 795950416@qq.com

    Not yet recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

    Zhihu Li, Master, 18993042850, zhihu_li666@163.com

    Not yet recruiting

  • Linyi People's Hospital

    Linyi, Shandong, 276000

    Zhongming Zhang, Master, 13853912929, rtog@163.com

    Not yet recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong, 276034

    Zhen Li, bachelor, 13869908100, lizhensdly@126.com

    Not yet recruiting

  • Lishui Central Hospitall

    Lishui, Zhejiang, 323000

    Yanru Xie, Master, 13567615770, 43437677@qq.com

    Not yet recruiting

  • Luoyang Central Hospital

    Luoyang, Henan, 471000

    Yang Wu, Master, 15037902968, wuyangly1975@163.com

    Not yet recruiting

  • The First Affiliated Hospital Of Henan University of Science and Technology

    Luoyang, Henan, 471000

    Jun Yao, Doctor, 13663790098, yaojun74@163.com

    Not yet recruiting

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514000

    Xiaoyang Wang, Bachelor, 13543209534, 1002192141@qq.com

    Not yet recruiting

  • Nanchang University First Affiliated Hospital

    Nanchang, Jiangxi, 330006

    Wei Wu, Master, 15070001599, 3077844463@qq.com

    Not yet recruiting

  • The Second Affiliated Hospital Of Nangchang University

    Nanchang, Jiangxi, 330006

    Hua Wang, Doctor, 13667098735, wanghua202107@163.com

    Not yet recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Rongfeng Song, Master, 13879172671, rfeng3471@163.com

    Not yet recruiting

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

    Yan Gui, Master, 15882618827, 15882618827@163.com

    Not yet recruiting

  • Jiangsu Provincial Cancer Hospital

    Nanjing, Jiangsu, 210009

    Delin Liu, Doctor, 13814077476, 76179757@qq.com

    Not yet recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210009

    Jia Wei, Doctor, 13951785234, jiawei99@nju.edu.cn

    Not yet recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Xiaofeng Chen, Doctor, 13585172066, Xiaofengch198019@126.com

    Not yet recruiting

  • Guangxi Medical University Afiliated Tomor Hospital

    Nanning, Guangxi, 530000

    Yuzhou Tan, Doctor, 13978807419, qyz402@126.com

    Not yet recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226300

    Lei Yang, Doctor, 15851398092, leiyang.53@163.com

    Not yet recruiting

  • Nanyang Second General Hospital

    Nanyang, Henan, 473000

    Yuan Liu, Master, 13937732728, liuyuan2003@163.com

    Not yet recruiting

  • The First affiliated Hospital of Nanyang Medical College

    Nanyang, Henan, 474450

    Xiuli Yang, bachelor, 15837768885, yangxiuli66979829@163.com

    Not yet recruiting

  • Qingdao Municipal Hospital (Group)

    Qingdao, Shandong, 266100

    Xiaomei Xu, Master, 18661675699, xuxiaomei7171@qq.com

    Not yet recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200001

    Zhiwang Song, Doctor, 15879135730, 15879135730@qq.com

    Not yet recruiting

  • ZhongShan Hospital

    Shanghai, Shanghai Municipality, 200030

    Xuefei Wang, Doctor, 13917270428, wang.xuefei@zs-hospital.sh.cn

    Not yet recruiting

  • Shanghai GoBroad Cancer Hospital China Pharmaceutical University

    Shanghai, Shanghai Municipality, 200131

    Jin Li, Doctor, 13761222111, lijin@csco.org.cn

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321

    Mingzhu Huang, Doctor, 18017317456, mingzhuhuang0718@163.com

    Not yet recruiting

  • Shantou University Medical College Affiliated Tumor Hospital

    Shantou, Guangdong, 515000

    Yi Jiang, Bachelor, 13553389578, Jiangzy_123@sina.com

    Not yet recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Jing Liu, Doctor, 18940250301, liujing23@vip.163.com

    Not yet recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110801

    Jingdong Zhang, Master, 13804027878, 13804027878@163.com

    Not yet recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110801

    Xiujuan Qu, Doctor, 13604031355, qu_xiujuan@hotmail.com

    Not yet recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050035

    Fei Yin, Doctor, 13831120022, yinfei_4y@sina.com

    Not yet recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Weiming Duan, Doctor, 13812681590, wmduan@163.com

    Not yet recruiting

  • The Fourth Affiliated Hospital Of Soochow University (SuZhou Du Shu Lake Hospital)

    Suzhou, Jiangsu, 215124

    Min Tao, Doctor, 13962125300, taomin@suda.edu.cn

    Not yet recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

    Wenhui Yang, Doctor, 15835133400, yangwenhui10012@163.com

    Not yet recruiting

  • First Hospital Of Shan Xi Medical University

    Taiyuan, Shanxi, 30001

    Yusheng Wang, Doctor, 13834646436, wangyusheng1972@163.com

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300300

    Ting Deng, Doctor, 15802243063, xymcdengting@126.com

    Not yet recruiting

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

    Yun Tang, Master, 13899880718, ae717ty@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

    Rui Mao, Doctor, 13899999440, 42492768@qq.com

    Not yet recruiting

  • Weifang Yidu Central Hospital

    Weifang, Shandong, 262500

    Peng Wang, Doctor, 13562677025, wangpeng1920@sohu.com

    Not yet recruiting

  • Wenzhou Medical University Affiliated First Hospital

    Wenzhou, Zhejiang, 325000

    Liping Tao, Master, 13676799069, drlipingtao@163.com

    Not yet recruiting

  • Tongji Hospital Tongji Medical College Of Hust

    Wuhan, Hubei, 430030

    Hong Qiu, Doctor, 13986296106, tjqiuhong@163.com

    Not yet recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Xinjun Liang, Doctor, 13995607152, doctorlxj@163.com

    Not yet recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 433000

    Hongli Liu, Doctor, 13995680822, hongli_liu@hust.edu.cn

    Not yet recruiting

  • The First Affiliated Hospital Of Wannan Medical College

    Wuhu, Anhui, 241001

    Lili Sheng, Doctor, 13605535185, shenglili@yjsyy.com

    Not yet recruiting

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu, 730000

    Peng Nie, Master, 15294333003, nie.peng2008@163.com

    Not yet recruiting

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710000

    Jun Bai, Doctor, 13186055863, edgemen@163.com

    Not yet recruiting

  • Xijing Hospital

    Xi'an, Shaanxi, 710032

    Yongzhan Nie, Doctor, 15091520001, nieyongzhan@qq.com

    Not yet recruiting

  • The Second Affiliated Hospital of PLA Air Force Military Medical University

    Xi'an, Shaanxi, 710038

    Haichuan Su, Doctor, 18629190366, cntdgcp@163.com

    Not yet recruiting

  • The First Affiliated Hospital Of Xi 'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Aili Suo, Doctor, 18991232561, Ailisuo@mail.xjtu.edu.cn

    Not yet recruiting

  • The First Affiliated Hospital Of Xiamen University

    Xiamen, Fujian, 361003

    Jiayi Li, Master, 13799792820, ljy778848@qq.com

    Not yet recruiting

  • QinghaiI University Affiliated Hospital

    Xining, Qinghai, 810000

    Yushuang Luo, Doctor, 13897208152, 13897208152@163.com

    Not yet recruiting

  • Xuzhou central hospital

    Xuzhou, Jiangsu, 221000

    Yuan Yuan, Doctor, 15351687303, www8866@163.com

    Not yet recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221004

    Zhengxiang Han, Doctor, 18052268612, cnhzxyq@163.com

    Not yet recruiting

  • Affiliated Hospital of Yangzhou Univrtsity

    Yangzhou, Jiangsu, 225000

    Haiyan Mao, Doctor, 13511740862, mysea001@163.com

    Not yet recruiting

  • Subei People's Hospital of Jiangsu province

    Yangzhou, Jiangsu, 225001

    Xianwen Zhang, Doctor, 18051060926, zhangxwok@163.com

    Not yet recruiting

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

    Li Jia, Master, 13303590063, 875567887@qq.com

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Hong Zong, Doctor, 13523586882, zonghong522@126.com

    Not yet recruiting

  • Henan Provincial Cancer Hospital

    Zhengzhou, Henan, 450003

    Ning Li, Doctor, 13526501903, Lining@126.com

    Not yet recruiting

  • The Second Affiliated Hospital Of Zunyi Medical University

    Zunyi, Guizhou, 550002

    Hang Zhou, Master, 13985619032, Zhouhang6618@sina.com

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized, Open-Label, Multicenter Phase III Study of Tecotabart Vedotin Plus Tislelizumab Versus Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With CLDN18.2-Positive, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients with CLDN18.2 positivity.

Conditions
Adenocarcinoma
Being tested
LM-302 Injection, Tislelizumab, Oxaliplatin Injection, Capecitabine Tablets
Medical subject headings
Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LM-302 InjectionDrug

    The LM-302 injection is an ADC drug targeting CLDN18.2.

  • TislelizumabDrug

    Tislelizumab is a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1).

  • Oxaliplatin InjectionDrug

    Oxaliplatin injection is a platinum-based antitumor drug.

  • Capecitabine TabletsDrug

    Capecitabine tablets belong to the fluorouracil-class prodrugs.

Study groups in NCT07385703
Study groupRoleWhat they receive
LM-302 Injection+TislelizumabExperimentalLM-302 Injection combined with Tislelizumab, 14days as a treatment cycle.
Receives: Drug: LM-302 Injection; Drug: Tislelizumab
Tislelizumab + oxaliplatin Injection +Capecitabine TabletsActive comparatorTislelizumab combined with oxaliplatin and capecitabine tablets, 21days as a treatment cycle.
Receives: Drug: Tislelizumab; Drug: Oxaliplatin Injection; Drug: Capecitabine Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    To compare the progression-free survival (PFS) of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who were previously untreated and had a PD-L1-positive status (CPS≥1) and high CLDN18.2 expression (≥75% 2+\&3+) with the LM-302 plus tislelizumab regimen versus the tislelizumab plus chemotherapy regimen in the LM-302 plus tislelizumab group and in all randomized populations. The PFS was assessed using blind independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) criteria.

    Measured: 1.5 years

Secondary outcomes (6)

  1. Overall Survival (OS)

    The preriod from the first use of the drug to death from all causes. For subjects who are still alive at the last follow-up, the OS will be counted as data censored based on the last follow-up. For subjects who are lost follow-up, the OS will be counted as data cesored based on the last confirmed survival time before being lost to follow-up.

    Measured: During the study period (Baseline up to two years)

  2. Progression-free survival (PFS) assessed by Investigator

    The period from the first use of the drug to disease progression or death (whichever occurs first).

    Measured: During the study period (Baseline up to two years)

  3. Objective Response Rate (ORR)

    The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first).

    Measured: During the study period (Baseline up to two years)

  4. Disease Control Rate (DCR)

    Proportion of subjects whose tumors shrink or remain stable for a certain period, including complete remission (CR), partial remission (PR) and stable disease (SD).

    Measured: During the study period (Baseline up to two years)

  5. Objective response rates (ORR)

    Proportion of patients whose tumors shrank by a certain amount and remained for a certain period of time, including complete response (CR) and partial response (PR) cases.

    Measured: During the study period (Baseline up to two years)

  6. Number of subjtecs with incidence of adverse events

    Number of subjtecs with incidence of adverse events: Occurrence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)

    Measured: During the study period (Baseline up to two years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start15 Apr 2026
  3. Primary completionOct 2028 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
752 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07385703
Sponsor's protocol ID
LM302-03-201
Status last verified
May 2026
First submitted
25 Jan 2026
Last updated
25 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LM-302 Injection, Tislelizumab and Oxaliplatin Injection in people with Adenocarcinoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 106 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lin Shen, Doctor (13911219511, dctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07385703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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