Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma

Study Overview
=================
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

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Sintilimab
* Drug: Bevacizumab
* Combination Product: Liver Protective Support Therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy | Drug: Sintilimab<br>* 200mg IV d1,Q3W<br>* Other names: IBI308;Drug: Bevacizumab<br>* 7.5mg/kg IV d1,Q3W<br>Combination Product: Liver Protective Support Therapy<br>* Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 3 years | 
| Overall survival (OS) | Defined as the time from the date of treatment start to the date of death | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | Defined as proportion of patients who have a best response of CR or PR | Up to 1 years | 
| Disease control rate (DCR) | Defined as proportion of patients who have a best response of CR, PR or SD | Up to 1 years | 
| Quality of Life (QoL) | The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0) | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, Sintilimab, Bevacizumab