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 ]

The incidence and grade of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03


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