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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616390
• Other study ID #: L20220940
• Status: Recruiting
• Phase: Phase 2
• Start date: November 9, 2022
• Est. completion date: November 2025

Study information

• Verified date: November 2022
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Huikai Li
• Phone: 862223340123
• Email: lihuikai[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2025
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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-?antibody, 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sintilimab
200mg IV d1,Q3W
• Bevacizumab
7.5mg/kg IV d1,Q3W

Combination Product:
• Liver Protective Support Therapy
Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall survival (OS)	Defined as the time from the date of treatment start to the date of death	Up to 3 years
Secondary	Overall response rate (ORR)	Defined as proportion of patients who have a best response of CR or PR	Up to 1 years
Secondary	Disease control rate (DCR)	Defined as proportion of patients who have a best response of CR, PR or SD	Up to 1 years
Secondary	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