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

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sintilimab; Drug: Bevacizumab; Combination Product: Liver Protective Support Therapy

• Registration Number: NCT05616390
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Study Start: 2022-11-09
• Study First Posted: 2022-11-15
• Last Update Submitted: 2023-03-19
• Last Update Posted: 2023-03-21
• Primary Completion: 2023-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Sintilimab	Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
experimental group	Liver Protective Support Therapy	Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
experimental group	Bevacizumab	Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China