NCT07533825

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
968

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Feb 2025Dec 2029

Study Start

First participant enrolled

February 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

April 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

February 12, 2026

Last Update Submit

April 9, 2026

Conditions

Gastric Cancer (GC)Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 3-year Overall Survival (OS)

    To compare the 3-year Overall Survival (OS) between the two groups.

    about 3 years

Secondary Outcomes (3)

  • Laparoscopic Detection Rate of Peritoneal Metastasis

    about 3 years

  • R0 Resection Rate

    about 3 years

  • Laparotomy Conversion Rate

    about 3 years

Study Arms (2)

Patients who undergo laparoscopic exploration

EXPERIMENTAL

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

Without undergoing laparoscopic exploration

ACTIVE COMPARATOR

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

Interventions

Laparoscopic Staging-Guided TherapyDEVICE

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

Patients who undergo laparoscopic exploration
Without Laparoscopic ExplorationDEVICE

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

Without undergoing laparoscopic exploration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed: Histologically proven adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II/III).
  • Definitive pathological markers: Documented status of HER2, MMR, CPS (PD-L1) score, and Claudin 18.2.
  • 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.
  • Age: 18 to 75 years, regardless of sex.
  • Performance status: ECOG score 0-2 (fully active to ambulatory and capable of self-care but unable to work).
  • Life expectancy: Estimated survival ≥ 6 months.
  • Surgical fitness: Adequate cardiopulmonary functional reserve and no contraindications to anesthesia.
  • Informed consent: Voluntary participation with written informed consent obtained.

You may not qualify if:

  • \. \*\*Gastric outlet obstruction:\*\* Requiring gastrojejunostomy due to obstructive symptoms.
  • \. \*\*Distant metastasis:\*\* Evidence of peritoneal, mesenteric, or omental metastasis and/or obvious ascites on imaging, or distant organ metastasis.
  • \. \*\*Other malignancies:\*\* History of or concurrent other malignant tumors (except curatively treated basal cell carcinoma of the skin).
  • \. \*\*Organ dysfunction:\*\* Severe cardiac insufficiency (NYHA class III-IV), hepatic dysfunction Child-Pugh class C, or creatinine clearance \< 30 mL/min.
  • \. \*\*Contraindications to laparoscopy:\*\* History of severe intra-abdominal adhesions, coagulation disorders (INR \> 1.5 or platelet count \< 50 × 10⁹/L), or severe intestinal obstruction.
  • \. \*\*Special populations:\*\* Pregnant or lactating women, or those unable to interrupt breastfeeding.
  • \. \*\*Mental status:\*\* Cognitive impairment or psychiatric disorders that preclude compliance with follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital,

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

April 16, 2026

Study Start

February 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2029

Last Updated

April 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)