A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer（PLC）or Biliary Tract Carcinoma (BTC)

Jiangsu HengRui Medicine Co., Ltd.7 个研究点分布在 1 个国家目标入组 157 人2017年4月24日

适应症Advanced Primary Liver Cancer Advanced Biliary Tract Carcinoma

干预措施SHR-1210 Apatinib FOLFOX4 GEMOX

概览

阶段: 2 期
干预措施: SHR-1210
疾病 / 适应症: Advanced Primary Liver Cancer
发起方: Jiangsu HengRui Medicine Co., Ltd.
入组人数: 157
试验地点: 7
主要终点: The Safety and Tolerability
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects with Advanced PLC.or BTC Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC or BTC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 or GEMOX regimen.

注册库

clinicaltrials.gov

开始日期

2017年4月24日

结束日期

2021年3月31日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Jiangsu HengRui Medicine Co., Ltd.

责任方

Sponsor

入排标准

入选标准

•Histologically confirmed advanced PLC or advanced BTC (including bile duct carcinoma and gallbladder carcinoma) ; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.
•Arm A:Failed or intolerable to at least one prior systemic treatment for advanced PLC. Arm B:No previous systemic treatment for advanced PLC or BTC
•ECOG Performance Status of 0 or
•Child-Pugh Class A or B with 7 points .
•Life Expectancy of at least 12 weeks.
•Has controlled infection by Hepatitis B Virus (HBV DNA\<500 IU/ml) or Hepatitis C Virus.
•Adequate organ function.
•Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug.
•Patient has given written informed consent.

排除标准

•Known fibrolamellar HCC; Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
•Known or occurrence of central nervous system (CNS) metastases.
•Ascites with clinical symptoms.
•Known or evidence of GI hemorrhage within the past 6 months.
•Known or occurrence of hemorrhage/ thrombus.
•Known or evidence of abdomen fistula, gastrointestinal perforation, or abdominal abscess within the past 2 months.
•Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
•Grade III\~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%.
•Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90 mmHg).
•Factors to affect oral administration (such as patients unable to swallow oral medications, chronic diarrhea and ileus etc. situations evidently affect drug oral medication and absorption).