Gastric CancerPhase 3NCT07789184

Radical Surgery Versus Non-Surgery in Gastric Cancer Patients With Peritoneal Metastasis After Successful Conversion Therapy

A Phase 3 study testing Radical Gastrectomy with D2 Lymphadenectomy and Standard Systemic Therapy for Advanced Gastric Cancer in people with Gastric Cancer and Peritoneal Metastasis, run by Hua Huang, MD, PhD at 31 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

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Trial summary

The goal of this clinical trial is to learn if radical surgery improves prognosis and quality of life compared with continued standard non-surgical treatment in gastric cancer patients with peritoneal metastasis who have achieved successful conversion therapy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Gastric Cancer, Peritoneal Metastasis
What is being tested?: Radical Gastrectomy with D2 Lymphadenectomy and Standard Systemic Therapy for Advanced Gastric Cancer
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 31 sitesChina
Study dates: 1 Dec 2026to 1 Oct 2031
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.
Age ≥ 18 years and ≤ 70 years.
Histologically and/or cytologically confirmed gastric cancer.
No evidence of gastric outlet obstruction or intestinal obstruction.
No distant metastasis on imaging examination. Initial laparoscopic exploration confirms CY0P1 or CY1P1, without distant organ metastasis, with a recorded peritoneal carcinomatosis index (PCI) ≤ 20, and with either positive or negative ascites. Patients meeting these criteria are eligible for pre-enrollment. Following successful conversion therapy, a second laparoscopic exploration must confirm conversion to CY0P0, with no distant organ metastases and no regional lymph node metastases beyond the second station. Only upon meeting these criteria are patients formally enrolled in the study.
No prior chemotherapy, targeted therapy, or immunotherapy.

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ECOG performance status score of 0-2.
Life expectancy ≥ 12 weeks.
Laboratory requirements: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 8 g/dL; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 1.5 × ULN. In the presence of liver metastases, AST and ALT ≤ 5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (CCr) ≥ 60 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

Who cannot join

Initial laparoscopic exploration reveals P0, or either of the two laparoscopic explorations reveals distant organ metastasis or distant lymph node metastasis.
Prior anticancer therapy, including chemotherapy, targeted therapy, or immunotherapy.
Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
Active bleeding or coagulation disorder within 2 months prior to enrollment, bleeding tendency, or ongoing thrombolytic therapy, deemed by the investigator as unsuitable for enrollment.
Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Left ventricular ejection fraction (LVEF) < 50% on echocardiography, or poorly controlled arrhythmia.
Known allergy to immunotherapy agents, chemotherapy agents, or any of their excipients.

Show all 10Show fewer

Pregnancy (positive pregnancy test prior to treatment initiation) or breastfeeding.
Active or uncontrolled severe infection: Severe infection within 4 weeks prior to enrollment (e.g., requiring intravenous antibiotics, antifungals, or antivirals); Known human immunodeficiency virus (HIV) infection; History of clinically significant liver disease, including viral hepatitis. For known hepatitis B virus (HBV) carriers, active HBV infection must be excluded, defined as HBV DNA positive (> 1 × 10⁴ copies/mL or > 2000 IU/mL); Known hepatitis C virus (HCV) infection with positive HCV RNA (> 1 × 10³ copies/mL), or other hepatitis, cirrhosis.
Urinalysis indicating proteinuria ≥ 2+, with 24-hour urine protein quantification > 1.0 g.
Any other condition deemed by the investigator as inappropriate for participation in this study.

Trial locations and contacts

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

Hua Huang contact

+86-13816151816

huahuang@fudan.edu.cn

City, postcode or hospital

Sites recruiting now only

31 sites in 1 country

China31 sites, 31 recruiting

Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
ziyu li, +86 010-88121122, ziyu_li@hsc.pku.edu.cn
Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
xiaohui du, +86 010-68182255, duxiaohui301@sina.com
Not yet recruiting
Peking University International Hospital
Beijing, Beijing Municipality, 102206
ning ning, +86 010-69006666, ningning301@126.com
Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
quan wang, +86 0431-88782222, wquan@jlu.edu.cn
Not yet recruiting
Changzhi People's Hospital
Changzhi, Shanxi, 046000
liang zong, +86 0355-2024990, 250537471@qq.com
Not yet recruiting
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400038
yan shi, +86 023-68765109, shiyanpwk@tmmu.edu.cn
Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
pin liang, +86 0411-83635963, sunnyliangpin@163.com
Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
huiyan luo, +86 020-87343571, luohy@sysucc.org.cn
Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
yanfeng hu, +86 020-61641888, banby@smu.edu.cn
Not yet recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
shi chen, +86 020-38254000, chensh47@mail.sysu.edu.cn
Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
jiaqi chen, +86 0571-87783777, 2311046@zju.edu.cn
Not yet recruiting
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
linghua zhu, +86 0571-86090073, 3198020@zju.edu.cn
Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
panpan yu, +86 0571-88122222, yupp0571@163.com
Not yet recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
jiankang zhu, +86 0531-89268763, 249217523@qq.com
Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
changqing jing, +86 0531-87938911, jingchangqing@sdfmu.edu.cn
Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
zhengrong li, +86 0791-88692748, lzr13@foxmail.com
Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
bin lai, +86 0791-86120120, Vincent83126@163.com
Not yet recruiting
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School
Nanjing, Jiangsu, 210008
jia wei, +86 025-83106666, jiawei99@nju.edu.cn
Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
chao yue, +86 025-83283597, yuechaomeng@126.com
Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
hao xu, +86 025-83718836, hxu@njmu.edu.cn
Not yet recruiting
Nantong First People's Hospital
Nantong, Jiangsu, 226001
shichun feng, +86 0513-81111888, fsc2200@126.com
Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
zhaojian niu, +86 0532-82911847, niuzhj@hotmail.com
Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hua Huang, MD, PhD, +86-13816151816, huahuang@fudan.edu.cn
Hua Huang, MD,PHD
Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality
yuan fang, +86 021-63240090, Fangyuan1231@aliyun.com
Not yet recruiting
ShangRao People's Hospital
Shangrao, Jiangxi, 334000
jinqiang chen, +86 0793-8100469, CJQ760624@126.com
Not yet recruiting
Tianjin Medical University Cancer Institute＆Hospital
Tianjin, Tianjin Municipality, 300060
xiangyang yu, +86 022-23109106, yxynankai@126.com
Not yet recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
wenbin zhang, +86 0991-7968088, zwb3216@sina.com
Not yet recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
guihua wang, +86 027-83665555, ghwang@tjh.tjmu.edu.cn
Not yet recruiting
The Second Affiliated Hospital of Airforce Military Medical University
Xi'an, Shaanxi, 710038
nan wang, +86 029-84777777, wangnandoc@fmmu.edu.cn
Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
peng xia, +86 029-85323200, peng_xia666@126.com
Not yet recruiting
Zhangzhou Affiliated hospital of Fujian Medical University
Zhangzhou, Fujian, 363000
lisheng cai, +86 0596-2082950, cailishengcls@163.com
Not yet recruiting

Other trials in China

About this study

Official title: A Prospective, Multicenter, Phase III Randomized Controlled Trial Evaluating the Impact of Radical Surgery Versus Non-Surgery on Prognosis and Quality of Life in Gastric Cancer Patients With Peritoneal Metastasis After Successful Conversion Therapy (ALANO Study, CGCA2603 Study)

Does radical surgery prolong overall survival in patients who achieve successful conversion therapy?
Does radical surgery provide better or at least comparable quality of life and safety outcomes compared with continued standard treatment? Researchers will compare radical surgery versus continued standard systemic treatment to see whether radical surgery provides superior clinical benefit for patients after successful conversion therapy.

Participants will:

Initial laparoscopic exploration confirms CY0P1 or CY1P1, absence of distant organ metastasis, a PCI ≤ 20, and presence or absence of ascites.
Receive conversion therapy (chemotherapy, targeted/immunotherapy, intraperitoneal therapy, etc.) per standard guidelines, tailored to the patient's condition and molecular-pathological profile
If clinical conversion is confirmed, undergo a second laparoscopic exploration to verify successful conversion
If successful conversion is confirmed (peritoneal lesions cleared or markedly regressed with negative biopsy, no ascites or distant metastases, R0-resectable primary tumor, and improved patient condition), be randomized 1:1 to either the surgery group or the standard treatment group
In the surgery group, undergo curative gastrectomy with D2 lymphadenectomy during the second laparoscopy, followed by adjuvant therapy and maintenance treatment
In the standard treatment group, continue systemic therapy without surgery, with maintenance treatment and salvage surgery permitted if clinically indicated
Complete quality of life questionnaires at predefined time points
Be followed up for survival, disease progression, adverse events and medical resource use outcomes

Conditions: Gastric Cancer, Peritoneal Metastasis
Being tested: Radical Gastrectomy with D2 Lymphadenectomy, Standard Systemic Therapy for Advanced Gastric Cancer
Medical subject headings: Stomach Neoplasms

What participants receive

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

Radical Gastrectomy with D2 LymphadenectomyProcedure or surgery
Patients undergo curative gastrectomy with D2 lymphadenectomy (laparoscopic, robotic, or open) during second-look laparoscopy after successful conversion therapy. Postoperatively, they receive adjuvant systemic therapy (continuing the preoperative regimen or MDT-modified protocol) for up to 8 cycles total, followed by maintenance therapy for up to 1 year after randomization, or until disease progression, unacceptable toxicity, or withdrawal.
Standard Systemic Therapy for Advanced Gastric CancerDrug
Patients do not undergo surgery. They continue the original conversion regimen or an MDT-adjusted systemic therapy for a total of 8 cycles, followed by maintenance therapy for up to 1 year after randomization, or until disease progression, unacceptable toxicity, or withdrawal. Salvage surgery is permitted if clinically indicated.

Study groups in NCT07789184
Study group	Role	What they receive
Surgery Group	Experimental	Not described Receives: Procedure: Radical Gastrectomy with D2 Lymphadenectomy
Standard Treatment Group	Active comparator	Not described Receives: Drug: Standard Systemic Therapy for Advanced Gastric Cancer

What is being measured

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

Overall Survival (OS)
Measured: Up to 3 years after randomization

Secondary outcomes (12)

Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires
Measured: Prior to first-look laparoscopy, prior to second-look laparoscopy, 1-month post-randomization, 3-months post-randomization, then every 3-months thereafter up to 3-years after randomization
Quality of Life (QoL) assessed by EORTC QLQ-STO22 questionnaires
Measured: Prior to first-look laparoscopy, prior to second-look laparoscopy, 1-month post-randomization, 3-months post-randomization, then every 3-months thereafter up to 3-years after randomization
Pathological Complete Response (pCR) Rate
Measured: At the time of radical surgery
R0 Resection Rate
Measured: At the time of radical surgery
Complication-Free Survival
Measured: Up to 3 years after randomization
Major Complication Rate
Measured: Within 30 days and 90 days after surgery
Progression-Free Survival (PFS) and Peritoneal PFS
Measured: Up to 3 years after randomization
Time to Peritoneal Re-dissemination
Measured: Up to 3 years after randomization
Length of Hospital Stay
Duration of postoperative hospital stay, calculated from the date of surgical intervention to the date of hospital discharge, only applicable to participants receiving surgical treatment.
Measured: Perioperative period
Readmission Rate
Measured: Within 30 days and 90 days post-surgery
Treatment Interruption Rate
Measured: Within 1-year after randomization
Direct Medical Costs / Hospitalization Costs
Direct medical costs are defined as all medical expenses directly related to the patient's care, including hospitalization, surgery, medications, laboratory tests, imaging examinations, and management of complications. Data will be collected continuously throughout the study period (from baseline until death or study completion) and aggregated at the end of the study.
Measured: Baseline through study completion, an average of 3-years post-randomization

Timeline

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

1 Dec 20261 Oct 2031

First posted27 Aug 2026
Study start1 Dec 2026 (estimated)
Primary completion1 Oct 2031 (estimated)
Study completion1 Oct 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric CancerStudies of the same condition, open and under way.
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: 170 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07789184
Sponsor's protocol ID: 2606346-6-2608A
Status last verified: Oct 2026
First submitted: 23 Aug 2026
Last updated: 16 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual-participant-level raw data will not be shared externally. Aggregated study results will be published in peer-reviewed journals.

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Phase III Randomized Controlled Trial Evaluating the Impact of Radical Surgery Versus Non-Surgery on Prognosis and Quality of Life in Gastric Cancer Patients With Peritoneal Metastasis After Successful Conversion Therapy (ALANO Study, CGCA2603 Study)
ClinicalTrials.gov ID: NCT07789184
Acronym / sponsor ID: 2606346-6-2608A
Conditions: Gastric Cancer, Peritoneal Metastasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 170 participants (estimated)
Lead sponsor: Hua Huang, MD, PhDUniversity, hospital or other
Study start: 1 Dec 2026 (estimated)
Primary completion: 1 Oct 2031 (estimated)
Study completion: 1 Oct 2031 (estimated)
First posted: 27 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Does radical surgery prolong overall survival in patients who achieve successful conversion therapy?
Does radical surgery provide better or at least comparable quality of life and safety outcomes compared with continued standard treatment? Researchers will compare radical surgery versus continued standard systemic treatment to see whether radical surgery provides superior clinical benefit for patients after successful conversion therapy.

Participants will:

Initial laparoscopic exploration confirms CY0P1 or CY1P1, absence of distant organ metastasis, a PCI ≤ 20, and presence or absence of ascites.
Receive conversion therapy (chemotherapy, targeted/immunotherapy, intraperitoneal therapy, etc.) per standard guidelines, tailored to the patient's condition and molecular-pathological profile
If clinical conversion is confirmed, undergo a second laparoscopic exploration to verify successful conversion
If successful conversion is confirmed (peritoneal lesions cleared or markedly regressed with negative biopsy, no ascites or distant metastases, R0-resectable primary tumor, and improved patient condition), be randomized 1:1 to either the surgery group or the standard treatment group
In the surgery group, undergo curative gastrectomy with D2 lymphadenectomy during the second laparoscopy, followed by adjuvant therapy and maintenance treatment
In the standard treatment group, continue systemic therapy without surgery, with maintenance treatment and salvage surgery permitted if clinically indicated
Complete quality of life questionnaires at predefined time points
Be followed up for survival, disease progression, adverse events and medical resource use outcomes

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Surgery Group	Experimental	Procedure: Radical Gastrectomy with D2 Lymphadenectomy
Standard Treatment Group	Active comparator	Drug: Standard Systemic Therapy for Advanced Gastric Cancer

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.
Age ≥ 18 years and ≤ 70 years.
Histologically and/or cytologically confirmed gastric cancer.
No evidence of gastric outlet obstruction or intestinal obstruction.
No distant metastasis on imaging examination. Initial laparoscopic exploration confirms CY0P1 or CY1P1, without distant organ metastasis, with a recorded peritoneal carcinomatosis index (PCI) ≤ 20, and with either positive or negative ascites. Patients meeting these criteria are eligible for pre-enrollment. Following successful conversion therapy, a second laparoscopic exploration must confirm conversion to CY0P0, with no distant organ metastases and no regional lymph node metastases beyond the second station. Only upon meeting these criteria are patients formally enrolled in the study.

Key exclusion criteria (10 listed)

Initial laparoscopic exploration reveals P0, or either of the two laparoscopic explorations reveals distant organ metastasis or distant lymph node metastasis.
Prior anticancer therapy, including chemotherapy, targeted therapy, or immunotherapy.
Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
Active bleeding or coagulation disorder within 2 months prior to enrollment, bleeding tendency, or ongoing thrombolytic therapy, deemed by the investigator as unsuitable for enrollment.
Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Left ventricular ejection fraction (LVEF) < 50% on echocardiography, or poorly controlled arrhythmia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radical Gastrectomy with D2 LymphadenectomyPatients undergo curative gastrectomy with D2 lymphadenectomy (laparoscopic, robotic, or open) during second-look laparoscopy after successful conversion therapy. Postoperatively, they receive adjuvant systemic therapy (continuing the preoperative regimen or MDT-modified protocol) for up to 8 cycles total, followed by maintenance therapy for up to 1 year after randomization, or until disease progression, unacceptable toxicity, or withdrawal.	Procedure or surgery	Surgery Group
Standard Systemic Therapy for Advanced Gastric CancerPatients do not undergo surgery. They continue the original conversion regimen or an MDT-adjusted systemic therapy for a total of 8 cycles, followed by maintenance therapy for up to 1 year after randomization, or until disease progression, unacceptable toxicity, or withdrawal. Salvage surgery is permitted if clinically indicated.	Drug	Standard Treatment Group

Primary outcome

Overall Survival (OS)
Time frame: Up to 3 years after randomization

12 secondary outcomes

Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires
Time frame: Prior to first-look laparoscopy, prior to second-look laparoscopy, 1-month post-randomization, 3-months post-randomization, then every 3-months thereafter up to 3-years after randomization
Quality of Life (QoL) assessed by EORTC QLQ-STO22 questionnaires
Time frame: Prior to first-look laparoscopy, prior to second-look laparoscopy, 1-month post-randomization, 3-months post-randomization, then every 3-months thereafter up to 3-years after randomization
Pathological Complete Response (pCR) Rate
Time frame: At the time of radical surgery
R0 Resection Rate
Time frame: At the time of radical surgery
Complication-Free Survival
Time frame: Up to 3 years after randomization
Major Complication Rate
Time frame: Within 30 days and 90 days after surgery
Progression-Free Survival (PFS) and Peritoneal PFS
Time frame: Up to 3 years after randomization
Time to Peritoneal Re-dissemination
Time frame: Up to 3 years after randomization
Length of Hospital Stay
Time frame: Perioperative period
Readmission Rate
Time frame: Within 30 days and 90 days post-surgery
Treatment Interruption Rate
Time frame: Within 1-year after randomization
Direct Medical Costs / Hospitalization Costs
Time frame: Baseline through study completion, an average of 3-years post-randomization

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Individual participant dataSharing planned: No. Individual-participant-level raw data will not be shared externally. Aggregated study results will be published in peer-reviewed journals.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Hua Huang contact

+86-13816151816

huahuang@fudan.edu.cn

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 10 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 Hua Huang (+86-13816151816, huahuang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 3 years after randomization). 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 NCT07789184.

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 16 Oct 2026.