NCT04992143

Brief Summary

According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.

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
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2021

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

August 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

August 20, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

August 1, 2021

Last Update Submit

February 14, 2023

Conditions

BCLC Stage C Hepatocellular Carcinoma

Keywords

BCLC Stage CHepatocellular CarcinomaTransarterial ChemoembolizationSorafenibTilelizumab

Outcome Measures

Primary Outcomes (1)

  • 1-year survival rate

    1-year survival rate assessed by Kaplan-Meier analysis

    at 1 year after enrolled

Secondary Outcomes (4)

  • Time to progression

    at 12 weeks and up to 2 years after enrolled

  • Progression free survival

    at 12 weeks and up to 2 years after enrolled

  • Objective response rate

    at 12 weeks and up to 2 years after enrolled

  • Disease control rate

    at 12 weeks and up to 2 years after enrolled

Study Arms (1)

TACE combined Tilelizumab and Sorafenib

EXPERIMENTAL

TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally)

Procedure: TACEDrug: TilelizumabDrug: Sorafenib

Interventions

TACEPROCEDURE

TACE first ,and more TACE could be performed when it is necessary.

TACE combined Tilelizumab and Sorafenib
TilelizumabDRUG

Tilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE

TACE combined Tilelizumab and Sorafenib
SorafenibDRUG

Sorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE

TACE combined Tilelizumab and Sorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Child-Pugh score≤ 7
  • HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019
  • the primary HCC being in BCLC C stage according to NCCN guideline
  • No previous systemic therapy for HCC

You may not qualify if:

  • Diffuse HCC
  • Uncontrolled ascites of hepatic encephalopathy
  • Prior liver transplantation
  • Positive for human immunodeficiency virus
  • Active gastric or duodenal ulcer
  • Other uncontrolled comorbidities or malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jun-hui Sun, MD,PH.D

    First Affiliated Hospital of Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Jun-hui Sun, MD,PH.D

CONTACT

+86-0571-872368151307005@zju.edu.cn

Tong-yin Zhu, MD

CONTACT

+86-0571-872368121513001@zju.edu.cn

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

August 1, 2021

First Posted

August 5, 2021

Study Start

August 20, 2021

Primary Completion

August 30, 2023

Study Completion

December 30, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)