Status:
UNKNOWN
A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC
Lead Sponsor:
Yanqiao Zhang
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 aim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03793725
Start Date
January 30 2019
End Date
January 30 2021
Last Update
January 4 2019
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