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

NCT ID: NCT03793725

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2021-01-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SHR1210

Intervention Type: DRUG

Anti-PD-1 Antibody

Apatinib

Intervention Type: DRUG

Anti-angiogenic drugs

Interventions

SHR1210

Anti-PD-1 Antibody

Intervention Type: DRUG

Apatinib

Anti-angiogenic drugs

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Yanqiao Zhang

OTHER

Sponsor Role: lead

Responsible Party

Yanqiao Zhang

Director of the hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhang Yanqiao, PHD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Harbin Medical University Cancer Hosptital

Central Contacts

Zhang Yanqiao, PHD

Role: CONTACT

yanqiaozhang@126.com

138 4512 0210

Wang Guangyu, PHD

Role: CONTACT

18249038966@163.com

18249038966

Other Identifiers

HZ-T-PD1-APA

Identifier Type: -

Identifier Source: org_study_id