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

NCT ID: NCT05616390

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy

Group Type EXPERIMENTAL

Sintilimab

Intervention Type DRUG

200mg IV d1,Q3W

Bevacizumab

Intervention Type DRUG

7.5mg/kg IV d1,Q3W

Liver Protective Support Therapy

Intervention Type COMBINATION_PRODUCT

Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy

Interventions

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Sintilimab

200mg IV d1,Q3W

Intervention Type DRUG

Bevacizumab

7.5mg/kg IV d1,Q3W

Intervention Type DRUG

Liver Protective Support Therapy

Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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IBI308

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huikai Li

Role: CONTACT

862223340123 ext. 3091

Facility Contacts

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Huikai Li

Role: primary

+862223340123 ext. 3091

Other Identifiers

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L20220940

Identifier Type: -

Identifier Source: org_study_id

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