A Phase III, Prospective, Multicenter, Randomized Controlled Trial of the Prognostic Impact of Laparoscopic Staging Laparoscopy in Patients With Clinical Stage III Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 968
- 试验地点
- 1
- 主要终点
- 3-year Overall Survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients who undergo laparoscopic exploration
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.
干预措施: Laparoscopic Staging-Guided Therapy (Device)
Without undergoing laparoscopic exploration
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.
干预措施: Without Laparoscopic Exploration (Device)
结局指标
主要结局
3-year Overall Survival (OS)
时间窗: about 3 years
To compare the 3-year Overall Survival (OS) between the two groups.
次要结局
- Laparoscopic Detection Rate of Peritoneal Metastasis(about 3 years)
- R0 Resection Rate(about 3 years)
- Laparotomy Conversion Rate(about 3 years)