NCT05616390

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

November 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 21, 2023

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

November 8, 2022

Last Update Submit

March 19, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaSintilimabBevacizumab

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Overall response rate (ORR)

    Up to 1 years

  • Disease control rate (DCR)

    Up to 1 years

  • Quality of Life (QoL)

    Up to 3 years

Study Arms (1)

experimental group

EXPERIMENTAL

Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy

Drug: SintilimabDrug: BevacizumabCombination Product: Liver Protective Support Therapy

Interventions

SintilimabDRUG

200mg IV d1,Q3W

Also known as: IBI308
experimental group
BevacizumabDRUG

7.5mg/kg IV d1,Q3W

experimental group
Liver Protective Support TherapyCOMBINATION_PRODUCT

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

experimental group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimabBevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Huikai Li

CONTACT

862223340123lihuikai@tjmuch.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 15, 2022

Study Start

November 9, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2025

Last Updated

March 21, 2023

Record last verified: 2022-11

Locations

CN(1)