NCT07533825Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 968 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07533825
What you commit to
- Study type: Interventional
- Planned participants: 968
- From 1 Feb 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.