Back to resultsSintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Bevacizumab
Liver Protective Support Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Sintilimab, Bevacizumab
Eligibility Criteria
Inclusion Criteria: Advanced unresectable hepatocellular carcinoma confirmed by histology or cytology Age 20-79 At least one measurable lesion defined in RECIST version 1.1 Child Pugh grade B ECOG PS score 2 The expected life is at least 90 days Exclusion Criteria: Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cells Received systemic corticosteroid or immunosuppressive therapy within 28 days before enrollment Complicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseases History of pleural or pericardial adhesions within 28 days before enrollment HIV antibody, HTV-Ⅰantibody, HCV antibody, hepatitis B surface protein antigen, hepatitis B surface protein antibody, hepatitis B core protein antibody or any detectable hepatitis B virus DNA test results were positive Multiple primary cancers (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and any other cancer that has not recurred for at least 5 years) Brain or meningeal metastasis (unless asymptomatic and does not require treatment) Uncontrollable or serious cardiovascular disease.
Sites / Locations
- Tianjin Medical University Cancer Institute & HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm Description
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
Outcomes
Primary Outcome Measures
Adverse Events (AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Overall survival (OS)
Defined as the time from the date of treatment start to the date of death
Secondary Outcome Measures
Overall response rate (ORR)
Defined as proportion of patients who have a best response of CR or PR
Disease control rate (DCR)
Defined as proportion of patients who have a best response of CR, PR or SD
Quality of Life (QoL)
The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)
Full Information
NCT ID
NCT05616390
First Posted
November 8, 2022
Last Updated
March 19, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05616390
Brief Title
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma
Official Title
A Study to Evaluate the Efficacy and Safety of the Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Child-Pugh B and/or ECOG PS 2 Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and 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
To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Sintilimab, Bevacizumab
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
experimental group
Arm Type
Experimental
Arm Description
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
IBI308
Intervention Description
200mg IV d1,Q3W
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
7.5mg/kg IV d1,Q3W
Intervention Type
Combination Product
Intervention Name(s)
Liver Protective Support Therapy
Intervention Description
Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy
Primary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Time Frame
Up to 3 years
Title
Overall survival (OS)
Description
Defined as the time from the date of treatment start to the date of death
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Defined as proportion of patients who have a best response of CR or PR
Time Frame
Up to 1 years
Title
Disease control rate (DCR)
Description
Defined as proportion of patients who have a best response of CR, PR or SD
Time Frame
Up to 1 years
Title
Quality of Life (QoL)
Description
The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced unresectable hepatocellular carcinoma confirmed by histology or cytology
Age 20-79
At least one measurable lesion defined in RECIST version 1.1
Child Pugh grade B
ECOG PS score 2
The expected life is at least 90 days
Exclusion Criteria:
Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cells
Received systemic corticosteroid or immunosuppressive therapy within 28 days before enrollment
Complicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseases
History of pleural or pericardial adhesions within 28 days before enrollment
HIV antibody, HTV-Ⅰantibody, HCV antibody, hepatitis B surface protein antigen, hepatitis B surface protein antibody, hepatitis B core protein antibody or any detectable hepatitis B virus DNA test results were positive
Multiple primary cancers (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and any other cancer that has not recurred for at least 5 years)
Brain or meningeal metastasis (unless asymptomatic and does not require treatment)
Uncontrollable or serious cardiovascular disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huikai Li
Phone
862223340123
Ext
3091
Email
lihuikai@tjmuch.com
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huikai Li
Phone
+862223340123
Ext
3091
Email
lihuikai@tjmuch.com
12. IPD Sharing Statement
Learn more about this trial
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma
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