HZ-T-PD1-APA: A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: SHR1210
Anti-PD-1 Antibody
Drug: Apatinib
Anti-angiogenic drugs
|
Outcome Measures
Primary Outcome Measures
- R0 (resection rate) [1 week after surgery]
R0 resection rate
Secondary Outcome Measures
- ORR [from the first drug administration up to one year]
Objective Response Rate
- RFS [from the first drug administration up to one year]
relapse free survival
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects voluntarily participate in this study and sign informed consent .
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Men or women aged 18-75 years
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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.
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The patients can swallow pills normally.
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ECOG score was 0 or 1.
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Have a life expectancy of at least 12 weeks.
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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
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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:
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Subjects had any active autoimmune disease or history of autoimmune disease.
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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.
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Subjects with severe allergic reactions to other monoclonal antibodies.
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The subjects had a central nervous system metastases of clinical symptoms.
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A heart condition or disease that is not well controlled.
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Subjects had active infections.
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Other clinical trials of drugs were used within 4 weeks prior to the first administration.
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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.
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There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Yanqiao Zhang
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
- Principal Investigator: Zhang Yanqiao, PHD, Study Principal Investigator Harbin Medical University Cancer Hosptital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HZ-T-PD1-APA