Clinical trial NCT03793725: A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2019-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: R0 (resection rate)
timeFrame: 1 week after surgery
Secondary outcomes:
measure: ORR
timeFrame: from the first drug administration up to one year
measure: RFS
timeFrame: from the first drug administration up to one year
Other outcomes:
Locations:
Study officials:
affiliation: Study Principal Investigator Harbin Medical University Cancer Hosptital
name: Zhang Yanqiao, PHD
role: PRINCIPAL_INVESTIGATOR
References: