Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Sintilimab, Bevacizumab
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
Interventions
DRUGSintilimab
200mg IV d1,Q3W
DRUGBevacizumab
7.5mg/kg IV d1,Q3W
COMBINATION_PRODUCTLiver Protective Support Therapy
Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to 3 years | 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) | Up to 3 years | Defined as the time from the date of treatment start to the date of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Up to 1 years | Defined as proportion of patients who have a best response of CR or PR |
| Disease control rate (DCR) | Up to 1 years | Defined as proportion of patients who have a best response of CR, PR or SD |
| Quality of Life (QoL) | Up to 3 years | The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0) |
Countries
China
Contacts
Primary ContactHuikai Li
Outcome results
None listed