Gastric Adenocarcinoma, Gastric Cancer (GC)
Conditions
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.
Detailed description
This study aims to compare, through a multicenter randomized controlled design, patients who undergo laparoscopic exploration staging before treatment (experimental group) with patients who receive treatment directly based on imaging findings (control group).Experimental Group: Will undergo laparoscopic exploration. If peritoneal metastasis (CY+ or P+) or cT4aN+ or cT4bN+ or M1 is found, recommendations include: Systemic therapy + NIPS ± HIPEC or HIPEC. If no metastasis is found, systemic neoadjuvant therapy is recommended.Control Group: Will not undergo laparoscopic exploration. Systemic therapy will be recommended directly based on imaging staging. The primary objective of this study is to compare the 3-year overall survival (OS) between the two groups (experimental group and control group). Overall survival is defined as the time from randomization or start of treatment to death from any cause, with the 3-year survival rate serving as the primary endpoint to evaluate the long-term survival benefit of the two treatment strategies. The secondary objectives of this study include the following three items:1.To evaluate the detection rate of peritoneal metastasis by laparoscopic staging (experimental group only).2.To evaluate the R0 resection rate after conversion surgery in both groups.3.To compare the surgical conversion rate (i.e., the proportion of patients who change from the original treatment plan to surgery) between the two groups.
Interventions
DEVICELaparoscopic 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
DEVICEWithout Laparoscopic Exploration
Patients undergo upfront systemic therapy without laparoscopic exploration and without intraperitoneal drug administration.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Peking University International Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking University People's Hospital
First Hospital of China Medical University
The First Hospital of Jilin University
Liaoning Cancer Hospital & Institute
Hebei Medical University Fourth Hospital
Changzhi People's Hospital
Shaanxi Provincial People's Hospital
General Hospital of Ningxia Medical University
Lanzhou University Second Hospital
Qianfoshan Hospital
Shandong Provincial Hospital
Qilu Hospital of Shandong University
Yantai Yuhuangding Hospital
Shanghai Zhongshan Hospital
RenJi Hospital
Fudan University
Anhui Provincial Hospital
The First Affiliated Hospital with Nanjing Medical University
The Affiliated Hospital of Xuzhou Medical University
Zhejiang Cancer Hospital
Second Affiliated Hospital of Soochow University
Tongji Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Jiangxi Provincial Cancer Hospital
West China Hospital
Guangdong Provincial People's Hospital
Fujian Medical University Union Hospital
Fujian Cancer Hospital
Tang-Du Hospital
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Overall Survival (OS) | about 3 years | To compare the 3-year Overall Survival (OS) between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laparoscopic Detection Rate of Peritoneal Metastasis | about 3 years | Detection Rate of Peritoneal Metastasis by Laparoscopic Exploration (DRPM-LE). This refers to the proportion of patients in whom peritoneal metastasis (including peritoneal seeding or positive peritoneal cytology) is identified via laparoscopic exploration. This outcome measure is used to assess the diagnostic value of laparoscopic staging in detecting peritoneal metastasis among patients with clinical stage III gastric cancer, and serves as a key parameter for evaluating the effectiveness of precision staging approaches. |
| R0 Resection Rate | about 3 years | R0 Resection Rate After Conversion Surgery |
| Laparotomy Conversion Rate | about 3 years | This refers to the proportion of patients in whom a laparoscopic procedure (exploration or surgery) is converted to open surgery due to factors such as extensive tumor invasion, technical difficulty, or intraoperative complications. This outcome measure assesses the safety and feasibility of laparoscopic staging and serves as a key indicator of whether precision staging effectively avoids unnecessary laparotomy in patients with clinical stage III gastric cancer. |
Countries
China
Outcome results
None listed