Laparoscopic Staging for Stage III Gastric Cancer

Summary

This study aims to determine, through a multicenter randomized controlled design, the impact of precision treatment guided by laparoscopic staging on overall survival (OS), surgical conversion rate, and peritoneal metastasis rate in patients with clinical stage III gastric cancer, thereby providing evidence for precision staging and treatment decision-making.

Conditions

• Gastric Cancer (GC)
• Gastric Adenocarcinoma

Interventions

DEVICE

Laparoscopic Staging-Guided Therapy

This intervention consists of a treatment strategy guided by findings from laparoscopic staging. If laparoscopic exploration reveals peritoneal metastasis (CY+ or P+), cT4aN+, cT4bN+, or M1 disease: Patients receive systemic therapy combined with NIPS (neoadjuvant intraperitoneal and systemic chemotherapy) ± HIPEC (hyperthermic intraperitoneal chemotherapy), or HIPEC alone. If laparoscopic exploration shows no peritoneal metastasis and the patient is cT3N+: Patients receive systemic neoadjuvant therapy alone, followed by imaging evaluation every 3-4 cycles and planned surgery. Postoperative treatment for the experimental group: After conversion therapy and surgery, systemic therapy + NIPS ± HIPEC or HIPEC is recommended. This intervention is distinguished from the comparator arm (which proceeds directly to systemic therapy without laparoscopic exploration and without intraperitoneal drug administration) by its use of laparoscopic staging to tailor treatment intensity and route, inc

DEVICE

Without Laparoscopic Exploration

Patients undergo upfront systemic therapy without laparoscopic exploration and without intraperitoneal drug administration.

Sponsors & Collaborators

• Peking University International Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Changzhi People's Hospital

  collaborator OTHER

• Shaanxi Provincial People's Hospital

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Qilu Hospital of Shandong University

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Jiangxi Provincial Cancer Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Tang-Du Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2026-12-31

Completion

2029-12-31

Countries

• China

Study Locations