A Study to Evaluate SHR-1210 in Subjects With Advanced HCC

A Randomized Controlled Multicentered Phase 2/3 Study to Evaluate SHR-1210 (PD-1 Antibody) in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Failed or Intolerable to Prior Systemic Treatment

This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210 in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and Overall Survival when compare with SOC.

In June 2017, this study was revised to expand the Phase 2 part to enroll more subjects and remove the Phase 3 part under the same protocol. A Phase 3 study will be initiated separately.

Inclusion Criteria:

1. Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
2. Failed or intolerable to at least one prior systemic treatment for advanced HCC
3. ECOG Performance Status of 0 or1
4. Child-Pugh Class A or B with 7 points
5. Life Expectancy of at least 12 weeks
6. HBV DNA<500 IU/ml
7. Adequate organ function
8. 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

Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Known liver transplant or plan to transplant
3. GI hemorrhage with 6 months
4. History or current brain metastases
5. Active known, or suspected autoimmune disease