Laparoscopic Staging for Stage III Gastric Cancer (CGCA202501)

A Phase III, Prospective, Multicenter, Randomized Controlled Trial of the Prognostic Impact of Laparoscopic Staging Laparoscopy in Patients With Clinical Stage III Gastric Cancer

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastric Adenocarcinoma; Gastric Cancer (GC)
• Intervention / Treatment: Device: Laparoscopic Staging-Guided Therapy; Device: Without Laparoscopic Exploration

Detailed Description

This study aims to compare, through a multicenter randomized controlled design, patients who undergo laparoscopic exploration staging before treatment (experimental group) with patients who receive treatment directly based on imaging findings (control group).Experimental Group: Will undergo laparoscopic exploration. If peritoneal metastasis (CY+ or P+) or cT4aN+ or cT4bN+ or M1 is found, recommendations include: Systemic therapy + NIPS ± HIPEC or HIPEC. If no metastasis is found, systemic neoadjuvant therapy is recommended.Control Group: Will not undergo laparoscopic exploration. Systemic therapy will be recommended directly based on imaging staging.

The primary objective of this study is to compare the 3-year overall survival (OS) between the two groups (experimental group and control group). Overall survival is defined as the time from randomization or start of treatment to death from any cause, with the 3-year survival rate serving as the primary endpoint to evaluate the long-term survival benefit of the two treatment strategies.

The secondary objectives of this study include the following three items:1.To evaluate the detection rate of peritoneal metastasis by laparoscopic staging (experimental group only).2.To evaluate the R0 resection rate after conversion surgery in both groups.3.To compare the surgical conversion rate (i.e., the proportion of patients who change from the original treatment plan to surgery) between the two groups.

• Study Type: Interventional
• Enrollment (Estimated): 968
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologically confirmed: Histologically proven adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II/III).
2. Definitive pathological markers: Documented status of HER2, MMR, CPS (PD-L1) score, and Claudin 18.2.

3. Clinical stage: cT3/T4a N+ M0 based on contrast-enhanced CT, endoscopic ultrasound, or MRI (AJCC 8th edition):

   cT3: Tumor invades through the muscularis propria into the subserosa. cT4a: Tumor penetrates the visceral peritoneum. cN+: Regional lymph node metastasis (intra-abdominal regional nodes such as perigastric, celiac, or common hepatic artery lymph nodes: short-axis diameter > 8 mm; other nodes such as retroperitoneal or para-aortic lymph nodes: short-axis diameter > 10 mm).

   No evidence of peritoneal metastasis on imaging modalities other than laparoscopic exploration.

4. Age: 18 to 75 years, regardless of sex.
5. Performance status: ECOG score 0-2 (fully active to ambulatory and capable of self-care but unable to work).
6. Life expectancy: Estimated survival ≥ 6 months.
7. Surgical fitness: Adequate cardiopulmonary functional reserve and no contraindications to anesthesia.
8. Informed consent: Voluntary participation with written informed consent obtained.

Exclusion Criteria:

• 1. **Gastric outlet obstruction:** Requiring gastrojejunostomy due to obstructive symptoms.

  2. **Distant metastasis:** Evidence of peritoneal, mesenteric, or omental metastasis and/or obvious ascites on imaging, or distant organ metastasis.

  3. **Other malignancies:** History of or concurrent other malignant tumors (except curatively treated basal cell carcinoma of the skin).

  4. **Organ dysfunction:** Severe cardiac insufficiency (NYHA class III-IV), hepatic dysfunction Child-Pugh class C, or creatinine clearance < 30 mL/min.

  5. **Contraindications to laparoscopy:** History of severe intra-abdominal adhesions, coagulation disorders (INR > 1.5 or platelet count < 50 × 10⁹/L), or severe intestinal obstruction.

  6. **Special populations:** Pregnant or lactating women, or those unable to interrupt breastfeeding.

  7. **Mental status:** Cognitive impairment or psychiatric disorders that preclude compliance with follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients who undergo laparoscopic exploration; Patients with peritoneal metastasis (CY+ or P+) or cT4aN+ or M1 disease receive systemic therapy + NIPS ± HIPEC or HIPEC alone. In cases without peritoneal metastasis and for patients with cT3N+, systemic neoadjuvant therapy is administered.	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
Active Comparator: Without undergoing laparoscopic exploration; Without undergoing laparoscopic exploration, patients receive upfront systemic therapy without intraperitoneal drug administration. Systemic therapy: Treatment regimen is selected based on molecular marker testing results and in accordance with gastric cancer treatment guidelines. There is no limit on the number of neoadjuvant or conversion therapy cycles; imaging evaluation is required every 3 to 4 cycles. Surgical treatment: Surgery is performed according to each center's treatment assessment and plan. Intraoperative exploration will determine the following: If R0 resection is achievable, D2 or D2+ radical gastrectomy is performed; If partial response is achieved but R0 resection remains infeasible, the procedure is concluded, and conversion therapy with the original regimen or second-line therapy is continued. Post-surgery, maintenance therapy with the original regimen is recommended until disease progression.	Device: Without Laparoscopic Exploration; Patients undergo upfront systemic therapy without laparoscopic exploration and without intraperitoneal drug administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year Overall Survival (OS)	To compare the 3-year Overall Survival (OS) between the two groups.	about 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laparoscopic Detection Rate of Peritoneal Metastasis	Detection Rate of Peritoneal Metastasis by Laparoscopic Exploration (DRPM-LE). This refers to the proportion of patients in whom peritoneal metastasis (including peritoneal seeding or positive peritoneal cytology) is identified via laparoscopic exploration. This outcome measure is used to assess the diagnostic value of laparoscopic staging in detecting peritoneal metastasis among patients with clinical stage III gastric cancer, and serves as a key parameter for evaluating the effectiveness of precision staging approaches.	about 3 years
R0 Resection Rate	R0 Resection Rate After Conversion Surgery	about 3 years
Laparotomy Conversion Rate	This refers to the proportion of patients in whom a laparoscopic procedure (exploration or surgery) is converted to open surgery due to factors such as extensive tumor invasion, technical difficulty, or intraoperative complications. This outcome measure assesses the safety and feasibility of laparoscopic staging and serves as a key indicator of whether precision staging effectively avoids unnecessary laparotomy in patients with clinical stage III gastric cancer.	about 3 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Zhejiang Cancer Hospital; Peking University People's Hospital; Fudan University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Shanghai Zhongshan Hospital; Fujian Cancer Hospital; RenJi Hospital; West China Hospital; Tongji Hospital; Qilu Hospital of Shandong University; Peking University International Hospital; Shandong Provincial Hospital; Jiangxi Provincial Cancer Hospital; Guangdong Provincial People's Hospital; Shaanxi Provincial People's Hospital; The First Hospital of Jilin University; Qianfoshan Hospital; Fujian Medical University Union Hospital; Hebei Medical University Fourth Hospital; Renmin Hospital of Wuhan University; Tang-Du Hospital; First Hospital of China Medical University; General Hospital of Ningxia Medical University; Second Affiliated Hospital of Soochow University; The Affiliated Hospital of Xuzhou Medical University; Anhui Provincial Hospital; Yantai Yuhuangding Hospital; Changzhi People's Hospital; Lanzhou University Second Hospital; Liaoning Cancer Hospital & Institute; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: E20251149; TJYXZDXK-3-003A (Other Grant/Funding Number: Tianjin Key Medical Discipline Construction Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No