A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC

A Phase II , Open-label , Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With Apatinib in Patients With Unresectable Hepatocellular Carcinoma

This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular Carcinoma.

This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of unresectable HCC.

Inclusion Criteria:

• Subjects voluntarily participate in this study and sign informed consent .
• Men or women aged 18-75 years
• patients with Unresectable HCC confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
• The patients can swallow pills normally.
• ECOG score was 0 or 1.
• Have a life expectancy of at least 12 weeks.
• The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
• Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.

Exclusion Criteria:

• Subjects had any active autoimmune disease or history of autoimmune disease.
• Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
• Subjects with severe allergic reactions to other monoclonal antibodies.
• The subjects had a central nervous system metastases of clinical symptoms.
• A heart condition or disease that is not well controlled.
• Subjects had active infections.
• Other clinical trials of drugs were used within 4 weeks prior to the first administration.
• The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
• There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.