Back to resultsA Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC (HZ-T-PD1-APA)
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR1210
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-1210 + Apatinib
Arm Description
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
Outcomes
Primary Outcome Measures
R0 (resection rate)
R0 resection rate
Secondary Outcome Measures
ORR
Objective Response Rate
RFS
relapse free survival
Full Information
NCT ID
NCT03793725
First Posted
January 3, 2019
Last Updated
January 3, 2019
Sponsor
Yanqiao Zhang
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03793725
Brief Title
A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2019 (Anticipated)
Primary Completion Date
January 30, 2020 (Anticipated)
Study Completion Date
January 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanqiao Zhang
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1210 + Apatinib
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
SHR1210
Intervention Description
Anti-PD-1 Antibody
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Anti-angiogenic drugs
Primary Outcome Measure Information:
Title
R0 (resection rate)
Description
R0 resection rate
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
from the first drug administration up to one year
Title
RFS
Description
relapse free survival
Time Frame
from the first drug administration up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Yanqiao, PHD
Phone
138 4512 0210
Email
yanqiaozhang@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Guangyu, PHD
Phone
18249038966
Email
18249038966@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Yanqiao, PHD
Organizational Affiliation
Study Principal Investigator Harbin Medical University Cancer Hosptital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC
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