Prospective Study With HIPEC-AS in Patients With Locally Advanced, Limited or Extensive Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 157
- 主要终点
- 3-year Overall Survival, OS
研究概览
简要总结
HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include "cT4aNxM0, P0 or cTxNxM1, P1" patients with gastric or esophagogastric junction adenocarcinoma, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period. Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c. The primary purpose is to evaluate the 3-year overall survival rate.
详细描述
HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include Patients With cT4aNxM0, P0, or cTxNxM1*, P1 Adenocarcinoma of the Stomach or Esophagogastric Junction, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period.
Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c.
Intervention:
Group A: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).
Group B: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •18 years old ≤ age ≤ 75 years old;
- •The primary gastric lesion was diagnosed as gastric or esophagogastric junction adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and poorly differentiated adenocarcinoma. )
- •The tumor is located in the stomach or esophagogastric junction (Siewert type II/III)
- •The preoperative clinical staging is cT4aNxM0, P0 or cTxNxM1*, P1 (*no other distant metastases except peritoneal metastasis)
- •Good bone marrow reserve function: HB≥90g/L; ANC ≥1.5×10*9/L; PLT ≥80×10*9/L
- •Good liver and kidney function reserve: BIL ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5×ULN; Crea≤1×ULN;
- •Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN
- •ECOG (Eastern Cooperative Oncology Group) physical status score 0-2;
- •No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc;
- •Written informed consent.
排除标准
- •There are distant metastases other than peritoneal metastases;
- •Complications of gastric cancer require emergency treatment, such as bleeding, perforation, obstruction, etc.;
- •Suffer from other malignant tumors within five years;
- •Body temperature ≥38℃ or complicated with infectious diseases requiring systemic treatment;
- •If there is a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, the investigator will determine whether the clinical severity hinders the signing of informed consent or affects the patient's compliance with oral medications;
- •Clinically serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention, or recent history of myocardial infarction within 12 months;
- •Severe respiratory diseases;
- •Severe liver and kidney dysfunction;
- •Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome, which may affect the absorption of oral drugs;
- •Diseases such as severe diabetes, hyperthyroidism and hypothyroidism have not been clinically controlled.
- •Those who continue to use glucocorticoid therapy within 1 month (except for local application) or who require immunosuppressive therapy for organ transplantation;
- •Pregnant or lactating women;
- •The patient has participated or is participating in other clinical studies (within 6 months);
研究组 & 干预措施
Group A
patients with locally resectable GC (cT4aNxM0, P0)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: HIPEC (Procedure)
Group A
patients with locally resectable GC (cT4aNxM0, P0)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: Paclitaxel-albumin (Drug)
Group A
patients with locally resectable GC (cT4aNxM0, P0)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: Tegafur-gimeracil-oteracil potassium (Drug)
Group A
patients with locally resectable GC (cT4aNxM0, P0)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: Surgery+HIPEC (Procedure)
Group B
patients with peritoneal metastasis stage P1a or P1b (cTxNxM1, P1a or P1b)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: HIPEC (Procedure)
Group B
patients with peritoneal metastasis stage P1a or P1b (cTxNxM1, P1a or P1b)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: Paclitaxel-albumin (Drug)
Group B
patients with peritoneal metastasis stage P1a or P1b (cTxNxM1, P1a or P1b)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: Tegafur-gimeracil-oteracil potassium (Drug)
Group B
patients with peritoneal metastasis stage P1a or P1b (cTxNxM1, P1a or P1b)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: Surgery+HIPEC (Procedure)
Group C
group C is patients with peritoneal metastasis stage P1c (cTxNxM1, P1c)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: HIPEC (Procedure)
Group C
group C is patients with peritoneal metastasis stage P1c (cTxNxM1, P1c)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: Paclitaxel-albumin (Drug)
Group C
group C is patients with peritoneal metastasis stage P1c (cTxNxM1, P1c)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3)
干预措施: Tegafur-gimeracil-oteracil potassium (Drug)
结局指标
主要结局
3-year Overall Survival, OS
时间窗: 3 years
The time from the date of enrollment of the patient to the date of death or the date of the last follow-up
次要结局
- NCI CTC Adverse Events Version 4.0(1 year)
- 3-year Progression Free Survival, PFS(3 years)
研究者
Xuefei.Wang
Professor
Shanghai Zhongshan Hospital