Tirellizumab Combined With SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: A Single-arm, Phase II Clinical Trial (Solids-03)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- One year overall survival
研究概览
简要总结
For peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma (cT3-4NanyM1), PD-1 antibody combined with chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) can downstage tumor stage, increase the conversion resection rate, and may improve the long-term survival. Tislelizumab, an anti-PD-1 antibody, has recently been proved in the first- and second-line standard treatment for advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma.In the subgroup analysis of RATIONALE-305 trial, tislelizumab also showed good efficacy in gastric/gastroesophageal junction adenocarcinoma patients with peritoneal metastasis. Combination of tirellizumab,SOX and HIPEC for peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative tirellizumab in combination with SOX and HIPEC in peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma.
详细描述
The incidence of gastric and gastroesophageal junction adenocarcinoma is increasing, and it is one of the most common malignant tumors in China. Surgery is the only possible way to cure gastric and gastroesophageal junction adenocarcinoma. Peritoneal metastasis is one of the most common modes of spread of gastric cancer. For gastric cancer with peritoneal metastasis, surgical treatment alone can not improve overall survival. Perioperative immunotherapy plus chemotherapy can downstage tumor T and N stage, increase the R0 resection rate, and may improve the long-term survival. Currently, surgical treatment combined with hyperthermic intraperitoneal chemotherapy (HIPEC) and systemic chemotherapy has demonstrated promising outcomes in both the treatment and prevention of peritoneal metastasis in gastric cancer. However, the therapeutic effects of immunotherapy combined with chemotherapy and HIPEC for gastric cancer with peritoneal metastasis remains unclear to date. Combination of perioperative tislelizumab and SOX plus HIPEC for peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase conversion resection rate and overall survival. This monocenter, single-arm phase 2 clinical trial aims to evaluate the effectiveness of tislelizumab plus SOX and HIPEC regimens in patients with peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma to determine the optimal therapeutic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed informed consent Patients age 18-75 years Histologically CT/MRI confirmed cT3-4NanyM1 gastric or GEJ adenocarcinoma; Peritoneal metastasis was confirmed by laparoscopy (with or without Krukenberg tumor ) The degree of peritoneal metastasis ≤P1b or PCI≤13 points ECOG 0-1, no surgery contraindications; Expected survival ≥3 months;
排除标准
- •Prior chemotherapy, radiotherapy, surgery for gastric cancer; Signs of other distant metastases (e.g., liver, lung, bone, supraclavicular lymph, etc.) Significant cardiovascular disease Major surgical procedure within 4 weeks prior to initiation of study treatment Current treatment with anti-viral therapy or HBV Pregnancy or breastfeeding History of malignancy within 5 years prior to screening Present or history of any autoimmune disease or immune deficiency Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors Poorly controlled hypertension or diabetes
研究组 & 干预措施
Tislelizumab plus SOX and HIPEC
Tislelizumab, chemotherapy (SOX), and HIPEC(Docetaxel or paclitaxel)
干预措施: Paclitaxel (Drug)
Tislelizumab plus SOX and HIPEC
Tislelizumab, chemotherapy (SOX), and HIPEC(Docetaxel or paclitaxel)
干预措施: Oxaliplatin (Drug)
Tislelizumab plus SOX and HIPEC
Tislelizumab, chemotherapy (SOX), and HIPEC(Docetaxel or paclitaxel)
干预措施: Docetaxel (Drug)
Tislelizumab plus SOX and HIPEC
Tislelizumab, chemotherapy (SOX), and HIPEC(Docetaxel or paclitaxel)
干预措施: Tislelizumab (Drug)
Tislelizumab plus SOX and HIPEC
Tislelizumab, chemotherapy (SOX), and HIPEC(Docetaxel or paclitaxel)
干预措施: S-1 (Drug)
结局指标
主要结局
One year overall survival
时间窗: From the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years
次要结局
- R0 resection rate(Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.)
- Major Pathological Response Rate (MPR)(From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.)
- Objective Response Rate (ORR)(From the initiation date of first cycle (each cycle is 21 days) to the date of last cycle, an average of 12 weeks)