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Trial Title:
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma
NCT ID:
NCT05616390
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Conditions: Keywords:
Hepatocellular Carcinoma
Sintilimab
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
200mg IV d1,Q3W
Arm group label:
experimental group
Other name:
IBI308
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
7.5mg/kg IV d1,Q3W
Arm group label:
experimental group
Intervention type:
Combination Product
Intervention name:
Liver Protective Support Therapy
Description:
Medical treatment such as liver protection therapy, antiviral therapy, platelet and
granulocyte upgrading therapy
Arm group label:
experimental group
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
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Huikai Li
Phone:
+862223340123
Phone ext:
3091
Email:
lihuikai@tjmuch.com
Start date:
November 9, 2022
Completion date:
November 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05616390
