Endometrial CancerPhase 3NCT06475599
Anlotinib Hydrochloride Capsules Combined With TQB2450 in the Treatment of Endometrial Cancer
A Phase 3 study testing Anlotinib hydrochloride capsule + TQB2450 injection and Chemotherapy drug in people with Endometrial Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 61 sites in China.
Trial summary
To demonstrate that anlotinib hydrochloride capsules combined with TQB2450 injection can significantly prolong progression-free survival (PFS) compared with chemotherapy in patients with recurrent or metastatic endometrial cancer that is non- microsatellite instability high (non-MSI-H) or DNA mismatch repair deficient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Anlotinib hydrochloride capsule + TQB2450 injection and Chemotherapy drug
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 61 sitesChina
- Study dates
- Jul 2024to Jun 2029
- Phase
- Phase 3
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
- Recurrent or metastatic advanced endometrial cancer confirmed by histopathology;
- Patients failed to respond to 1-2 lines of platinum-based doublet-based therapy;
- Provide a traceable MMR/MSI status report or provide biological samples for DNA mismatch repair/microsatellite instability (MMR/MSI) status testing with non-MSI-high (non-MSI-H) or non-dMMR；
- Patients who cannot undergo radical surgery/radiotherapy;
- Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-1; The expected survival time is more than 3 months；
- At least one measurable lesion (RECIST 1.1);
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- Good function of the major organs；
- Women of childbearing age should agree that they must use a contraceptive method (e.g. Intra-uterine device (IUD), contraceptive pill, or condom) during the study and for 6 months after the study; A negative serum pregnancy test within 7 days before study entry and must be non-lactating；
- Subjects voluntarily joined this study, signed informed consent, and had good compliance；
Who cannot join
- Previous use of bevacizumab, endostar, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib and other anti-angiogenic drugs or immunotherapy drugs targeting programmed cell death protein 1 (PD-1), PD-L1 and other related cells；
- Patients received anti-tumor indications of Chinese patent medicine approved by National Medical Products Administration (NMPA) within 2 weeks before the study treatment；
- Pathology suggested carcinosarcoma (malignant mullerian mixed tumor), endometrial leiomyosarcoma or other high-grade sarcoma, or endometrial stromal sarcoma；
- Hormone therapy for endometrial cancer had been received within 1 week before the first dose of trial medication；
- Surgery, chemotherapy, radiation therapy, or other anticancer therapy had been received within 4 weeks before the initiation of study treatment (the washout period was calculated from the end of the last treatment). The half-life of oral targeted drugs was less than 5 drugs；
- Subjects with known central nervous system metastases and/or carcinomatous meningitis; The patients were not asymptomatic or were treated and stable, had no radiographic evidence of new or expanding brain metastases for at least 2 weeks after treatment for brain metastases, and had discontinued steroids or anticonvulsant therapy for at least 14 days before the initiation of study treatment；
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- The patient had developed or had concurrent malignant tumors within the past 3 years；
- Multiple factors that affect the oral administration of anlotinib (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction) may affect the oral absorption of anlotinib；
- Uncontrolled pleural, pericardial, or ascites requiring repeated drainage (investigator judgment); Severe bone injury caused by tumor bone metastasis may occur or occur after enrollment；
- Patients whose imaging (CT or MRI) showed that the tumor had invaded the important blood vessels or the investigators judged that the tumor was likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study；
- Unmitigated toxic effects higher than CTCAE grade 1 due to any previous antineoplastic therapy, excluding alopecia；
- Major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the first dose；
- A wound or fracture that has not healed for a long time；
- Patients with a history of arterial/venous thrombosis/cancer thrombosis within 6 months before the first dose of drug, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism；
- People who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders；
- Subjects with any severe and/or uncontrolled illness；
- A history of vaccination with live attenuated vaccine within 28 days before the initiation of study treatment or a planned vaccination with live attenuated vaccine during the study；
- Patients with severe allergic disease, history of severe drug allergy, and known allergic to any component of the trial drug prescription;；
- Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressive agents) had developed within 2 years before the initiation of study treatment；
- Patients who are diagnosed with immunodeficiency or who are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (at a dose of >10mg/ day of prednisone or other equivalent efficacy hormone) and continue to do so within 2 weeks before the first dose; Major surgical treatment or significant traumatic injury within 4 weeks before the first dose in this study；
- Participated in other clinical trials of antineoplastic drugs within 4 weeks before the first dose；
- Subjects with concomitant diseases that seriously endanger the safety of the subjects or interfere with the completion of the study, or those who were considered to be unsuitable for enrollment for other reasons according to the investigator's judgment.
Trial locations and contacts
61 sites in 1 country. Contact the study team or a site near you to ask about taking part.
61 sites in 1 country
China61 sites
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, 100006
Yue He, Doctor, 13681565788, yueyue870610@ccmu.edu.cn
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020
Hua Li, Doctor, 18600878877, hual_gyn@163.com
Binzhou Medical University Hospital
Binzhou, Shandong, 256600
Fangling Ning, Master, 15254311599, ningfangling@126.com
Binzhou People's Hospital
Binzhou, Shandong, 256601
Huanlian Yang, Master, 13854358141, 13854358141@163.com
Changchun Tumor Hospital
Changchun, Jilin, 130012
Yigai Ma, Bachelor, 13910286029, 18686660731@163.com
The first hospital of Jilin University
Changchun, Jilin, 130021
Ziling Liu, Doctor, 13943001600, drzilingliu@163.com
Hunan Cancer Hospital
Changsha, Hunan, 410031
Keqiang Zhang, Doctor, 13054196067, zhangkeqiang@hnca.org.cn
Chongqing University Cancer Hospital
Chongqing, 400032
Dong Wang, Bachelor, 13708301293, cqwindow120@163.com
The Southwest Hospital of Amu
Chongqing, 400038
Yanzhou Wang, Doctor, 18680893816, wangyanzhou1981@126.com
Chongqing University Three Gorges Hospital
Chongqing, 400040
Shichuan Chang, Master, 17323861001, cshchuan@sina.com
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400072
Xiaojing Dong, Doctor, 13648437247, xffdoctor@163.com
The Affiliated Hospital of Southwest Medical University
Chongqing, 646000
Dan Li, Doctor, 15884169140, lidan0918@163.com
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yang Sun, Doctor, 15959028989, doctorsunyang@sina.com
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510289
Bingzhong Zhang, Doctor, 13925063030, 13925063030@163.com
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Yuan Shen, Doctor, 18102606438, missyy@126.com
Guigang City People's Hospital
Guigang, Guangxi, 537100
Yan Wei, Bachelor, 13321686622, wyan184@163.com
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 541000
Yufei Pan, Master, 13737740520, 23865934@qq.com
Hainan Ceneral Hospital
Haikou, Hainan, 570311
Genhai Zhu, Doctor, 13876082272, genhaizhu@163.com
Maternal Health School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Xiaodong Cheng, Doctor, 13958039839, chengxd@zju.edu.cn
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Hanmei Lou, Master, 13456856364, louhm@zjcc.org.cn
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yunyan Zhang, Postdoctor, 13604843878, zhangyunyan-1972@163.com
Anhui Provincial Hospital
Hefei, Anhui, 230001
Ying Zhou, Doctor, 13865901025, 13865901025@139.com
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010017
Liying Xue, Master, 18047192517, xuelyup@126.com
Huizhou Central People's Hospital
Huizhou, Guangdong, 516008
Hailin Xiong, Doctor, 15976198371, Xiong0752@hotmail.com
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030
Xiaohong Ruan, Doctor, 139 2468 0902, ruanxiaohong@jmszxyy.com.cn
Shandong Cancer Hospital
Jinan, Shandong, 250117
Hao Yu, Doctor, 15953105039, fishdoctor@yeah.net
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272001
Xiaowei Liu, Bachelor, 18678766867, jnfylxw@163.com
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Linlin Yang, Doctor, 13085369125, yll194900@sina.com
First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Chang Liu, Doctor, 13893479248, 44025660@qq.com
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Qingming Zhang, Bachelor, 13321339133, 1043536297@qq.com
Linyi Cancer Hospital
Linyi, Shandong, 276000
Xiumin Li, Master, 13583991399, Lyzlyylxm@163.com
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Chanjuan He, Master, 18077226717, 114457843@qq.com
Liuzhou Municipal Liutie Central Hospital
Liuzhou, Guangxi, 545007
Guiping Lai, Bachelor, 13768875556, 562795946@qq.com
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 450018
Xinshuai Wang, Doctor, 13837986128, xshuaiw@126.com
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Jingna Wu, Bachelor, 13431819838, wujingna@mzrmyy.com
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Qingjie Zhang, Doctor, 15278015900, 1583825050@qq.com
Nanyang first People's Hospital National Third Class A Hospital
Nanyang, Henan, 473000
Zhen Zhang, Master, 13663997000, zhangzhen1771@163.com
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315201
Jun Chen, Master, 13777975439, cjcj992@163.com
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xiaohua Wu, Doctor, 18121299168, wu.xh@fudan.edu.cn
Shanghai Tenth People's Hospital
Shanghai, 200040
Xiaojun Chen, Doctor, 13601680784, cxjlhjj@163.com
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, 200090
Xuezhen Luo, Doctor, 13472887368, xuezhenluo2013@163.com
The Central Hospital Of Shaoyang
Shaoyang, Hunan, 422000
Xinfu Liu, Doctor, 15807397520, 4194478@qq.com
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000
Danbo Wang, Doctor, 18940251157, danbo_wang@126.com
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110000
Song Gao, Doctor, 18940251511, gaos@sj-hospital.org
Shanxi Cancer hospital
Taiyuan, Shanxi, 030000
Hongwei Zhao, Doctor, 13633412660, inmind20060829@126.com
Shanxi Bethune Hospital
Taiyuan, Shanxi, 30000
Haixia Shang, Doctor, 13623678770, shx_mail2004@163.com
Tangshan People's Hospital
Tangshan, Hebei, 063000
Ping Wang, Doctor, 18931505881, wangshjzh@163.com
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300181
Ke Wang, Master, 18622221098, 18622221098@163.com
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, 300199
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Guqun Shen, Master, 18609007670, 382709897@qq.com
Weifang People's Hospital
Weifang, Shandong, 261000
Guohua Yu, Bachelor, 13793699977, ghyry@126.com
Yidu Central Hospital Of Weifang
Weifang, Shandong, 262500
Peng Wang, Doctor, 13562677025, wangpeng1920@sohu.com
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Huifeng Zhang, Master, 13871012421, Zhf20081217@126.com
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710038
Haichuan Su, Doctor, 18629190366, cntdgcp@163.com
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061
Ruifang An, Doctor, 189991232090, anruifang@163.com
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 712038
Lihong Chen, Doctor, 13689280015, lihongchen29@163.com
Qinghai Red Cross Hospital
Xining, Qinghai, 810000
Kuan Zhang, Bachelor, 18997081048, 875424616@qq.com
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Ying Yang, Doctor, 15966506506, hxdany2004@126.com
General Hospital Of Ningxia Medical University
Yinchuan, Ningxia, 750001
Yunxia Li, Bachelor, 13895071809, lyx1170@163.com
Tengzhou Central People's Hospital
Zaozhuang, Shandong, 277500
Kaixian Zhang, Bachelor, 13563200960, tengzhouzkx@126.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Liping Han, Doctor, 13619845906, hanliping0825@163.com
About this study
Official title: Efficacy of Anlotinib Hydrochloride Capsules Combined With TQB2450 in the Treatment of Endometrial Cancer in a Randomized, Controlled, Open-label, Multicenter Phase III Clinical Trial
To demonstrate that anlotinib hydrochloride capsules combined with TQB2450 injection can significantly prolong progression-free survival (PFS) compared with chemotherapy in patients with recurrent or metastatic endometrial cancer that is non- microsatellite instability high (non-MSI-H) or DNA mismatch repair deficient (non-dMMR).
- Conditions
- Endometrial Cancer
- Being tested
- Anlotinib hydrochloride capsule + TQB2450 injection, Chemotherapy drug
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochloride capsule + TQB2450 injectionDrug
Anlotinib hydrochloride capsule is a multi-target tyrosine kinase inhibitor, which targets VEGFR (VEGFR-1, VEGFR-2 and VEGFR-3), PDGFR, FGFR and c-Kit, etc. It can inhibit tumor progression by inhibiting angiogenesis and tumor growth at the same time.
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1) that prevents the binding of PD-L1 to the PD-1 and B7.1 receptors on the T-cell surface, allowing T-cell reactivation and thus enhancing the immune response.
Chemotherapy drugDrug
Based on each patient's condition and previous treatment history, the investigator will select one of the chemotherapy drugs (including Paclitaxel, Albumin, Doxorubicin and Doxorubicin hydrochloride) for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib hydrochloride capsules + TQB2450 injection | Experimental | Anlotinib hydrochloride capsule: 12 mg each time, once a day, oral administration before breakfast, continuous oral administration for 2 weeks and stop for 1 week.
TQB2450 injection: 1200mg/ time, once every 3 weeks, diluted to 250 mL with normal saline, infusion time was 60±10 minute. Receives: Drug: Anlotinib hydrochloride capsule + TQB2450 injection |
| Chemotherapy drug | Active comparator | Based on each patient's condition and previous treatment history, the investigator will select one of the following chemotherapy drugs for treatment.
Paclitaxel: dose of 175 mg /㎡, Day 1, every 4 weeks (Q4W). Albumin-bound paclitaxel: dose of 125 mg /㎡, Day 1, Day 8, Day 15, every 4 weeks (Q4W).
Doxorubicin: dose 60mg/m ², Day1, every 3 weeks (Q3W). Doxorubicin liposome: dose 40mg/ m ²,Day 1, every 4 weeks (Q4W). Receives: Drug: Chemotherapy drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by independent imaging review committee (IRC)
Progression-free survival (PFS) as assessed by independent imaging review committee (IRC) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST1.1) criteria.
Time from subject randomization (first treatment) to first disease progression or death from any cause, whichever occurred first.
Measured: Up to 36 months after study start
Secondary outcomes (12)
Overall survival (OS)
Time from randomization to death from any cause.
Measured: Up to 36 months after study start
Progression-free survival (PFS) assessed by investigators
Time from subject randomization (first treatment) to first disease progression or death from any cause, whichever occurred first, was assessed by the investigator according to RECIST 1.1.
Measured: Up to 36 months after study start
Objective mitigation rate (ORR)
According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements, namely the proportion of patients with complete response (CR) and partial response (PR).
Measured: Up to 36 months after study start
Duration of Response (DOR)
From the time of tumor first evaluated as complete or partial response to the time of first disease progression or death from various causes，if the tumor remission is not confirmed, it can not be used.
Measured: Up to 36 months after study start
Disease control rate (DCR)
According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements, namely the proportion of patients with CR，PR and stable disease (SD).
Measured: Up to 36 months after study start
Incidence and severity of abnormal laboratory values
Incidence and severity of laboratory inspection indicators exceed the normal range
Measured: Up to 36 months after study start
Incidence and severity of adverse event rate Adverse events (AE), serious adverse event (SAE)
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
Measured: Up to 36 months after study start
Incidence of dose interruptions, dose reductions, and dose discontinuations due to study-drug-related toxicity during the trial
Incidence of dose interruptions, dose reductions, and dose discontinuations due to study-drug-related toxicity during the trial
Measured: Up to 36 months after study start
Immunogenicity of TQB2450
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs)
Measured: Before administration (-15 minutes) in cycles 1, 2, 5, and 9, and 90 days after the last dose (±7days), each cycle is 21 days
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Questionnaire: EORTC Quality of Life Questionnaire (QLQ-C30):For questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good.
Measured: Up to 96 weeks
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Questionnaire: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) : The scale has numbers from 0 to 100. 100 represents the best health imaginable. 0 is the worst health imaginable.
Measured: Up to 96 weeks
European Organization for Research on Treatment of Cancer Endometrial cancer Specific scale QLQ-EN24
Questionnaire: European Organization for Research on Treatment of Cancer Quality of Life questionnaire 24 (QLQ-EN24)：From questions 1 to 24, choose a number from 1 to 4, where 1 means none and 4 means very much.
Measured: Up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475599
- Sponsor's protocol ID
- TQB2450-III-13
- Status last verified
- Jan 2024
- First submitted
- 21 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No