TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04992143

Collaborator

BeiGene (Beijing) Co., Ltd (Other)

Enrollment

Location

Arm

22.3

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
BCLC Stage C Hepatocellular Carcinoma	Procedure: TACE Drug: Tilelizumab Drug: Sorafenib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy and Safety of TACE Combined With Tilelizumab and Sorafenib in Treating BCLC Stage C HCC Patients: a Single-center, Single-arm, Prospective Clinical Study

Anticipated Study Start Date :

Aug 20, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TACE combined Tilelizumab and Sorafenib TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally)	Procedure: TACE TACE first ,and more TACE could be performed when it is necessary. Drug: Tilelizumab Tilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE Drug: Sorafenib Sorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE

Arm

Intervention/Treatment

Experimental: TACE combined Tilelizumab and Sorafenib

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

Procedure: TACE

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

Drug: Tilelizumab

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

Drug: Sorafenib

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

Outcome Measures

Primary Outcome Measures

1-year survival rate [at 1 year after enrolled]
1-year survival rate assessed by Kaplan-Meier analysis

Secondary Outcome Measures

Time to progression [at 12 weeks and up to 2 years after enrolled]
Time to progression assessed by independent radiologic review according to mRECIST criteria
Progression free survival [at 12 weeks and up to 2 years after enrolled]
Progression free survival assessed by independent radiologic review according to mRECIST criteria
Objective response rate [at 12 weeks and up to 2 years after enrolled]
Objective response rate assessed by independent radiologic review according to mRECIST criteria
Disease control rate [at 12 weeks and up to 2 years after enrolled]
Disease control rate assessed by independent radiologic review according to mRECIST criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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