Laparoscopic Staging for Stage III Gastric Cancer
Enrolling by invitation · Not applicable
Conditions studied: Gastric Cancer (GC), Gastric Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT07533825
- Run by
- Tianjin Medical University Cancer Institute and Hospital
- People needed
- 968
- Starts
- 2025-02-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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…
- 1. **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.
Where it is running
- Tianjin Medical University Cancer Institute and Hospital, — Tianjin, Tianjin Municipality, China
Full record on ClinicalTrials.gov
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