Clinical Trial: A Study of SHR-1210 in Combination With Apatinib or FOLFOX4 Regimen in Subjects With Advanced Primary Liver Cancer(PLC)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or FOLFOX4 Regimen in Subjects With Advanced Primary Liver Cancer(PLC)
Brief Summary:
This an open-label,Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or FOLFOX4 regimen in subjects with Advanced PLC.
Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 regimen.
Detailed Summary:
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Current Primary Outcome: The safety and tolerability [ Time Frame: Up to approximately 2years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- Duration of Response (DoR) [ Time Frame: Up to approximately 2 years ]Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- Disease Control Rate (DCR) [ Time Frame: Up to approximately 6 months2 years ]Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- Time to Progression (TTP) [ Time Frame: Up to approximately 2 years ]Time to Progression (TTP) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- Overall Survival [ Time Frame: Up to approximately 2 years ]Overal Survial will be calculated based on Kaplan-Meier estimates
Original Secondary Outcome: Same as current
Information By: Jiangsu HengRui Medicine Co., Ltd.
Dates:
Date Received: March 15, 2017
Date Started: April 27, 2017
Date Completion: December 2018
Last Updated: May 15, 2017
Last Verified: February 2017