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Can surgery after drug therapy beat drugs alone for stomach cancer spread?

NCT ID NCT07789184

Disease control Sponsor: Hua Huang, MD, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether adding radical surgery to remove the stomach tumor and nearby lymph nodes improves survival and quality of life compared with continuing drug therapy alone in patients with stomach cancer that has spread to the abdominal lining (peritoneal metastasis) and has responded well to initial conversion therapy. Participants who achieve successful conversion, confirmed by a second look inside the abdomen, are randomly assigned to either surgery followed by more drug therapy or to continued drug therapy without surgery. The study tracks overall survival, quality of life, and safety outcomes to see which approach offers better long-term benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radical gastrectomy with D2 lymphadenectomy (surgery) compared with continued standard systemic therapy (drugs)
What this could lead to
If surgery proves better, it could establish a new standard of care for patients whose stomach cancer spread to the abdominal lining has responded well to initial drug therapy, potentially extending survival and improving quality of life.
What could go wrong
This is a phase III trial, but surgery carries risks like complications from the operation, and the benefit over drug-only treatment is not yet proven. Results may not apply to all patients, and the trial is still recruiting or ongoing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm peritoneal carcinomatosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer Peritoneal metastasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011, China

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000, China

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School

    Nanjing, Jiangsu, 210008, China

  • Nantong First People's Hospital

    Nantong, Jiangsu, 226001, China

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Peking University International Hospital

    Beijing, Beijing Municipality, 102206, China

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021, China

  • ShangRao People's Hospital

    Shangrao, Jiangxi, 334000, China

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, China

  • Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400038, China

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong, 250014, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • The Second Affiliated Hospital of Airforce Military Medical University

    Xi'an, Shaanxi, 710038, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655, China

  • Tianjin Medical University Cancer Institute＆Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030, China

  • Zhangzhou Affiliated hospital of Fujian Medical University

    Zhangzhou, Fujian, 363000, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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