Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGSHR1210
Anti-PD-1 Antibody
DRUGApatinib
Anti-angiogenic drugs
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Yanqiao Zhang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 (resection rate) | 1 week after surgery | R0 resection rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFS | from the first drug administration up to one year | relapse free survival |
| ORR | from the first drug administration up to one year | Objective Response Rate |
Contacts
Primary ContactZhang Yanqiao, PHD
Backup ContactWang Guangyu, PHD
Outcome results
None listed