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

Hepatocellular Carcinoma Clinical Trial

— HZ-T-PD1-APA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03793725
• Other study ID #: HZ-T-PD1-APA
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 30, 2019
• Est. completion date: January 30, 2021

Study information

• Verified date: January 2019
• Source: Harbin Medical University
• Contact: Zhang Yanqiao, PHD
• Phone: 138 4512 0210
• Email: yanqiaozhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• SHR1210
Anti-PD-1 Antibody
• Apatinib
Anti-angiogenic drugs

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yanqiao Zhang	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 (resection rate)	R0 resection rate	1 week after surgery
Secondary	ORR	Objective Response Rate	from the first drug administration up to one year
Secondary	RFS	relapse free survival	from the first drug administration up to one year