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

Yanqiao Zhang0 sites30 target enrollmentJanuary 30, 2019

ConditionsHepatocellular Carcinoma

InterventionsSHR1210 Apatinib

DrugsSHR1210 Apatinib

Overview

Phase: Phase 2
Intervention: SHR1210
Conditions: Hepatocellular Carcinoma
Sponsor: Yanqiao Zhang
Enrollment: 30
Primary Endpoint: R0 (resection rate)
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 30, 2019

End Date

January 30, 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yanqiao Zhang

Responsible Party

Sponsor Investigator

Principal Investigator

Yanqiao Zhang

Director of the hospital

Harbin Medical University

Eligibility Criteria

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
•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.

Arms & Interventions

SHR-1210 + Apatinib

Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd

Intervention: SHR1210

SHR-1210 + Apatinib

Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd

Intervention: Apatinib