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NOT YET RECRUITING
NCT07789184
PHASE3

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

Sponsor: Hua Huang, MD, PhD

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

DRUG

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