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Radical Surgery Versus Non-Surgery in Gastric Cancer Patients With Peritoneal Metastasis After Successful Conversion Therapy
Sponsor: Hua Huang, MD, PhD
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
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)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2026-10-01
Completion Date
2031-10-01
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Radical Gastrectomy with D2 Lymphadenectomy
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 Cancer
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.
Locations (31)
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Zhangzhou Affiliated hospital of Fujian Medical University
Zhangzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School
Nanjing, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nantong First People's Hospital
Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
ShangRao People's Hospital
Shangrao, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The Second Affiliated Hospital of Airforce Military Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Changzhi People's Hospital
Changzhi, Shanxi, China
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China