Clinical trial · Interventional
Laparoscopic Staging for Stage III Gastric Cancer
A Phase III, Prospective, Multicenter, Randomized Controlled Trial of the Prognostic Impact of Laparoscopic Staging Laparoscopy in Patients With Clinical Stage III Gastric Cancer
NCT07533825CI-TRIAL-00108552CGCA202501enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Staging-Guided Therapy | Device | — | UNRESOLVED |
| Without Laparoscopic Exploration | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients who undergo laparoscopic exploration
- description
- 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.
- interventionNames
- Device: Laparoscopic Staging-Guided Therapy
- type
- ACTIVE_COMPARATOR
- label
- Without undergoing laparoscopic exploration
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.