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ENROLLING BY INVITATION

NCT07533825

Laparoscopic Staging for Stage III Gastric Cancer

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

968

Start Date

2025-02-01

Completion Date

2029-12-31

Last Updated

2026-04-16

Healthy Volunteers

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.

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.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital,

Tianjin, Tianjin Municipality, China