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SHR-1210 Plus Apatinib in Patients With Advanced-Stage Hepatocellular Carcinoma (SHR-1210)

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210
apatinib
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.≥18 years old, male or female 2.Advanced liver cancer (cannot be removed or metastasized) diagnosed clinically or pathologically, at least one measurable lesion without local treatment, Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C 3.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4.Patient has given written informed consent. 5.Previous treatment failure with sorafenib or rivastatin (disease of disease or toxicity) or unwillingness to accept, economically unsustainable sorafenib treatment; 6.The function of important organs meets the requirements 7.Expected survival ≥12 weeks 8.Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; non-surgical sterilization Female patients of childbearing age must have a negative serum or urine human chorionic gonadotropin(HCG) test within 72 hours prior to study enrollment; and must be non-lactating; for male patients with maternal age, they should be given SHR-1210 during the trial and after the last 3 effective methods of contraception within a month.

Exclusion Criteria:

- 1.The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included); 2.The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment; 3.Have clinical symptoms or disease that are not well controlled 4.Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization 5.Arterial/venous thrombosis in the first 6 months of randomization 6.According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.,with family or social factors, it will affect the safety of patients.

7.Liver tumor burden greater than 50% of the total liver volume, or patients who have previously undergone liver transplantation;Known for a history of central nervous system metastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonal antibodies;

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-1210+ apatinib

Arm Description

SHR-1210 was administered intravenously (without prophylaxis) at a fixed dose of 200 mg for 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 2 years; Apatinib was taken orally after meals, once a day, for continuous medication, and 1 cycle every 4 weeks.

Outcomes

Primary Outcome Measures

Objective response rate(ORR)
Evaluated by researchers based on the RECIST 1.1 standard

Secondary Outcome Measures

Progression free survival(PFS)
Evaluated by researchers based on the RECIST 1.1 standard
To the relief time (TOR)
Evaluated by researchers based on the RECIST 1.1 standard
Duration of relief(DOR)
Evaluated by researchers based on the RECIST 1.1 standard
Disease Control Rate (DCR)
Evaluated by researchers based on the RECIST 1.1 standard
9-month survival rate
12-month survival rate
Overall survival (OS)

Full Information

First Posted
July 8, 2019
Last Updated
July 10, 2019
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04014101
Brief Title
SHR-1210 Plus Apatinib in Patients With Advanced-Stage Hepatocellular Carcinoma
Acronym
SHR-1210
Official Title
A Single Arm Pilot Study of Programmed Cell Death Protein 1 Antibody (PD-1# SHR-1210 Combined With Apatinib Mesylate in Patients With Advanced-Stage Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

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
SHR-1210 is a humanized anti-PD-1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label#single center #non-randomized #Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial(IIT) .The objective of this study is to evaluate the efficacy and safety of therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with advanced stage hepatocellular carcinoma.

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
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR-1210+ apatinib
Arm Type
Experimental
Arm Description
SHR-1210 was administered intravenously (without prophylaxis) at a fixed dose of 200 mg for 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 2 years; Apatinib was taken orally after meals, once a day, for continuous medication, and 1 cycle every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Other Intervention Name(s)
Anti-PD-1 Antibody
Intervention Description
SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
apatinib
Intervention Description
Apatinib is a selective VEGFR2 inhibitor.
Primary Outcome Measure Information:
Title
Objective response rate(ORR)
Description
Evaluated by researchers based on the RECIST 1.1 standard
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression free survival(PFS)
Description
Evaluated by researchers based on the RECIST 1.1 standard
Time Frame
2 years
Title
To the relief time (TOR)
Description
Evaluated by researchers based on the RECIST 1.1 standard
Time Frame
2 years
Title
Duration of relief(DOR)
Description
Evaluated by researchers based on the RECIST 1.1 standard
Time Frame
2 years
Title
Disease Control Rate (DCR)
Description
Evaluated by researchers based on the RECIST 1.1 standard
Time Frame
2 years
Title
9-month survival rate
Time Frame
9-month
Title
12-month survival rate
Time Frame
12-month
Title
Overall survival (OS)
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.≥18 years old, male or female 2.Advanced liver cancer (cannot be removed or metastasized) diagnosed clinically or pathologically, at least one measurable lesion without local treatment, Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C 3.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4.Patient has given written informed consent. 5.Previous treatment failure with sorafenib or rivastatin (disease of disease or toxicity) or unwillingness to accept, economically unsustainable sorafenib treatment; 6.The function of important organs meets the requirements 7.Expected survival ≥12 weeks 8.Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; non-surgical sterilization Female patients of childbearing age must have a negative serum or urine human chorionic gonadotropin(HCG) test within 72 hours prior to study enrollment; and must be non-lactating; for male patients with maternal age, they should be given SHR-1210 during the trial and after the last 3 effective methods of contraception within a month. Exclusion Criteria: - 1.The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included); 2.The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment; 3.Have clinical symptoms or disease that are not well controlled 4.Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization 5.Arterial/venous thrombosis in the first 6 months of randomization 6.According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.,with family or social factors, it will affect the safety of patients. 7.Liver tumor burden greater than 50% of the total liver volume, or patients who have previously undergone liver transplantation;Known for a history of central nervous system metastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonal antibodies;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Fan, PHD
Phone
021 64041990/680774
Email
:fan.jia@zs-hospital.sh.cn
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
: Jia Fan, PHD
Phone
021 64041990/680774
Email
fan.jia@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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SHR-1210 Plus Apatinib in Patients With Advanced-Stage Hepatocellular Carcinoma

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