Prospective Randomized Phase II Clinical Trial: the Efficacy of Surgical Treatment in Combinations With Intraperitoneal Immunotherapy and Systemic Chemotherapy in Patients With Gastric Cancer and Verified Free Cancer Cells
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 主要终点
- Overall 2-year survival
研究概览
简要总结
The purpose of this study is to determine whether intraperitoneal immunotherapy (with interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more effective than systemic chemotherapy alone in patients with gastric cancer and verified free cancer cells in abdominal cavity in improving the long term outcomes and overall survival of further surgical treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven gastric cancer T2-3 N+, T4a with any N (0,+) with free cancer cells in the abdominal cavity and no macroscopic canceromathosis and no other distant metastases (TNM classification 7th edition)
- •Histological forms: gastric adenocarcinoma and signet ring cancer
- •Blood characteristics (creatinine <150 mg/l, total bilirubin < 50 mkmol/l, neutrophils < 1500/mkl, hemoglobin >90 g/l, thrombocytes > 100000/mkl)
排除标准
- •Clinically apparent distant metastasis (besides free cancer cells)
- •Synchronic or metachronic malignant tumors
- •Previous systemic or surgical or combined therapy for gastric cancer
- •Complications of gastric cancer (obstruction 0-1 GOOSS scale and/or gastric bleeding)
- •Adhesions in abdominal cavity
- •Gastrooesophageal junction cancer or gastric cancer with spreading on oesophagus.
研究组 & 干预措施
neoadjuvant chemoimmunotherapy
Patients with gastric cancer and verified free cancer cells who receive 1 course of intraperitoneal immunotherapy with interleykin-2 + 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -> M0) surgical treatment will be performed.
干预措施: neoadjuvant chemoimmunotherapy (Procedure)
neoadjuvant chemotherapy
Patients with gastric cancer and verified free cancer cells who receive 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -> M0) surgical treatment will be performed.
结局指标
主要结局
Overall 2-year survival
时间窗: 2 years
Overall 2-year survival for patients who received radical (R0) surgical treatment after downstaging (M1 -\> M0; Cyt "+" -\> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
次要结局
- Mortality(24 months)
- Portability of the systemic therapy methods(6,9,12,24 months)
- Downstaging tumor(2 years)
- Quality of life(6, 12, 18, 24 months)
- Morbidity(30 days)