A Single-arm, Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX (Gemcitabine Combined Oxaliplatin) in Patients With Advanced Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 6-month Progression Free Survival (PFS) rate
研究概览
简要总结
This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies.
In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.
28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.
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
- •Pathology confirmed biliary malignancy, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma.
- •Age:18-75 years, male or female.
- •The estimated survival period is more than 3 months.
- •There is at least one measurable lesion, according to the RECIST 1.1 standard.
- •Patients has not been treated by oxaliplatin, gemcitabine and pd-1 / pd-l1 antibody.
- •Patients who have been treated tegafur or capecitabine as adjuvant chemotherapy or first-line treatment may be selected.
排除标准
- •There were concurrent malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ.
- •Other drug clinical trials have been taken in four weeks.
- •Patients with a history of central nervous system metastasis or central nervous system metastasis are known before the screening.
- •Patients with a history of unstable angina.
- •The urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantification >1.0 g.
- •Have used immune-targeted therapy drugs.
- •The patient had received a liver transplant.
- •Having a history of chronic autoimmune diseases such as systemic lupus erythematosus.
- •Having a history of immunodeficiency, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
研究组 & 干预措施
SHR1210+GEMOX
This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment.
干预措施: SHR-1210+GEMOX (Drug)
结局指标
主要结局
6-month Progression Free Survival (PFS) rate
时间窗: from the first drug administration up to 6 months
the rate of 6-month progression free survival
Incidence of Treatment-Emergent Adverse Events
时间窗: from the first drug administration to within 90 days for the last SHR-1210 dose
Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events
次要结局
- Disease Control Rate (DCR)(from the first drug administration up to two years)
- Objective Response Rate (ORR)(from the first drug administration up to two years)
- Duration of response (DOR)(from the first drug administration up to two years)
- 12-month Overall survival (OS) rate(from the first drug administration up to approximately 12 months)
- OS(from the first drug administration up to 2 years)