A Phase II Study of Sintilimab Combined With Chemotherapy as Postoperative Adjuvant Treatment for Phase III Gastric Adenocarcinoma (GC) and The Adenocarcinoma of Esophagogastric Junction (GEJ)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 3-year disease free survival(DFS) rate
研究概览
简要总结
This study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection. After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX) , in which the combined chemotherapy is up to 8 cycles, and the total course of treatment was 16 cycles. The following-up of subjects includes adverse events、disease status、living conditions and the quality of life.
详细描述
This study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection that meets the criteria for group entry and does not meet the exclusion criteria. After signing the informed consent, the subjects entered the trial group to receive adjuvant treatment with Sintilimab combined with chemotherapy (SOX or XELOX ), in which SOX or XELOX chemotherapy was up to 8 cycles, and the total course of treatment was 16 cycles. The efficacy is evaluated every 4 cycles during the study treatment. The frequency of follow-up after treatment is defined as: once every 3 months within 2 years after surgery, every 6 months for 2 to 5 years, and once a year after 5 years. The follow-up interval can be adjusted according to the clinical need. Safety follow-up is from the beginning of the first treatment to 30 days after the last medication.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histopathological confirmed gastric/GEJ adenocarcinoma.
- •The pTNM is confirmed between IIIA-IIIC and the PD-L1 CPS>=
- •Patients treated with D2 surgery.
- •ECOG is 0 or
- •Patients who could tolerate chemotherapy combined with immunotherapy.
- •Patients who are not pregnant and have no willing to get pregnant within 6 months after the treatment is over.
- •Patients who are willing to offer their postoperative tumor tissue and their peripheral blood samples.
- •Patients who are volunteer to sign the ICF.
排除标准
- •Patients who had received neoadjuvent treatments before surgery.
- •Patients who have discovered tumor relapse or metastasis before adjuvent treatment.
- •Patients who have other malignant tumors.
- •Patients who could not swallow the tablets and capsules.
- •Other conditions which the researchers think are not suitable for participate the study.
研究组 & 干预措施
Sintilimab + SOX/XELOX
The study only has one experimental cohort that the subjects who enter the study will receive Sintilimab combined with SOX/XELOX up to 8 cycles, and then receive Sintilimab combined with Tegafur, Gimeracil and Oteracil Potassium Capsules or Capecitabine up to a year ( totally 16 cycles).
干预措施: Sintilimab plus Chemotherapy (Biological)
结局指标
主要结局
3-year disease free survival(DFS) rate
时间窗: From the time of first dose of adjuvant treatment to the 3 years of the same day
The disease free survival rate of 3 years after receiving the first dose of treatment
次要结局
- DFS(From the time of first dose of adjuvant treatment to the time when the subjects have confirmed disease progress)
- overall survival (OS)(From the time of first dose of adjuvant treatment to the time when the subjects have died for all causes)
- safety(collect all adverse events since the last medication up to 30 days)
研究者
LIN YANG
Doctor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences