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

NCT07789184 | Not Yet Recruiting Phase 3

• 1 other identifier: 2606346-6-2608A
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 31

Brief 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. The main questions it aims to answer are:

• 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

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Up to 3 years after randomization

Secondary Outcomes (12)

• Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires

  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

  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

  At the time of radical surgery

• R0 Resection Rate

  At the time of radical surgery

• Complication-Free Survival

  Up to 3 years after randomization

Study Arms (2)

Surgery Group

EXPERIMENTAL

Procedure: Radical Gastrectomy with D2 Lymphadenectomy

Standard Treatment Group

ACTIVE COMPARATOR

Drug: Standard Systemic Therapy for Advanced Gastric Cancer

Interventions

Radical Gastrectomy with D2 Lymphadenectomy PROCEDURE

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.

Surgery Group

Standard Systemic Therapy for Advanced Gastric Cancer DRUG

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.

Standard Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hua Huang, MD, PhD: lead

Study Sites (31)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, 102206, China

Location

The First Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

Zhangzhou Affiliated hospital of Fujian Medical University

Zhangzhou, Fujian, 363000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

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

Wuhan, Hubei, 430030, China

Location

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

Nanjing, Jiangsu, 210008, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Nantong First People's Hospital

Nantong, Jiangsu, 226001, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

ShangRao People's Hospital

Shangrao, Jiangxi, 334000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

The Second Affiliated Hospital of Airforce Military Medical University

Xi'an, Shaanxi, 710038, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location

Changzhi People's Hospital

Changzhi, Shanxi, 046000, China

Location

Tianjin Medical University Cancer Institute＆Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

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

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Hua Huang

CONTACT

+86-13816151816; huahuang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Gastric Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (31)