NCT05648487尚未招募2 期
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Sintilimab in Gastric Cancer With Peritoneal Metastasis
Affiliated Cancer Hospital & Institute of Guangzhou Medical University0 个研究点目标入组 46 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- R0 resection
研究概览
简要总结
To evaluate the Safety and Efficacy of HIPEC Combined With Sintilimab for Gastric Cancer Patients with Peritoneal Metastasis.
详细描述
Peritoneal metastasis is the most common pattern of disease relapse and is attributed to the dismal prognosis of the gastric cancer. The National Comprehensive Cancer Network (NCCN) guidelines suggest that systemic chemotherapy is the first-line standard strategy, and chemotherapy combined with trastuzumab for patients with positive HER-2. HIPEC can significantly improve survival in peritoneal metastasis from gastric cancer. PD-1/PD-L1 antibody has shown promising outcomes for unresectable or metastatic solid tumors. The present study aimed to evaluate the safety and efficacy of HIPEC combined with Sintilimab (Tyvyt®) in gastric cancer patients with peritoneal metastasis.
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
- •Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
- •Age 18-75 years, Male or Non pregnant female
- •ECOG (Eastern Cooperative Oncology Group) : 0~1；
- •Negative for HER-2 by IHC/FISH；
- •Peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20；
- •Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
- •Normal Bone marrow, liver and kidney function indices before the recruitment:
- •Expected survival≥ 12 week
- •Signed the Informed Consent Form, and blood and tissue samples can be obtained;
排除标准
- •Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);
- •Previous systemic therapy for gastric cancer;
- •Recurrent gastric cancer after surgery;
- •Cardiopulmonary dysfunction;
- •Immunosuppressive drugs(eg.Corticosteroids) were used within 14 days before treatment, eg.corticosteroids,
- •There is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and those who do not need any intervention after adulthood can be included Asthma requiring medical intervention with bronchodilator was not included.)
- •Allergy to the drugs in this protocol；
- •Patients with other diseases not suitable for inclusion, such as immune deficiency, active tuberculosis, hepatitis B (non-active hepatitis B surface antigen (HBsAg) carriers, hepatitis B virus titer <500IU/ml after treatment and with normal liver function can be included), hepatitis C virus positive;
- •A history of idiopathic pulmonary fibrosis, tissue pneumonia, drug pneumonia, idiopathic pneumonia, or r active pneumonia;
- •Other patients who were considered unsuitable for inclusion by the researchers;
研究组 & 干预措施
Gastric Cancer With Peritoneal Metastasis, HIPEC, Anti-PD-1 Antibody
Experimental
- Surgical exploration, if PCI≤20, then we perform this study.
- HIPEC: HIPEC is performed after laparoscopic exploration, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgical exploration;
- Chemotherapy(SOX) and anti-PD-1 antibody Sintilimab (Tyvyt®) treatment followed (4 cycles): SOX regimen: Oxaliplatin: 130 mg/m^2, IV, d1; S-1, 40-60 mg/m^2 bid, po, day 1-14, every 3 weeks for a total of 4 cycles; Sintilimab (Tyvyt®) 200mg fixed dose every 3 weeks, for a total of 4 cycles.
- Surgery: Imaging and secondary surgical exploration, assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases ). After the surgery, HIPEC for three cycles, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgery; For inoperable patients, continue to use standard chemotherapy.
- After the surgery, continue to use standard adjuvant chemotherapy.
干预措施: HIPEC,anti-PD-1 antibody Sintilimab (Tyvyt®), Chemotherapy,Surgery (Drug)
结局指标
主要结局
R0 resection
时间窗: 3 months
the rate of R0 resection
次要结局
- ORR(3 months)
- Event-Free Survival(2 years)
- Relapse-Free Survival(2 years)
- Overall survival time(2 years)
研究者
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