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

NCT ID: NCT04992143

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2023-12-30

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.

Conditions

BCLC Stage C Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE combined Tilelizumab and Sorafenib

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

Group Type: EXPERIMENTAL

TACE

Intervention Type: PROCEDURE

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

Tilelizumab

Intervention Type: DRUG

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

Sorafenib

Intervention Type: DRUG

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

Interventions

TACE

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

Intervention Type: PROCEDURE

Tilelizumab

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

Intervention Type: DRUG

Sorafenib

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

Intervention Type: DRUG

Eligibility Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun-hui Sun, MD,PH.D

Role: STUDY_DIRECTOR

First Affiliated Hospital of Zhejiang University

Locations

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun-hui Sun, MD,PH.D

Role: CONTACT

1307005@zju.edu.cn

+86-0571-87236815

Tong-yin Zhu, MD

Role: CONTACT

1513001@zju.edu.cn

+86-0571-87236812

Facility Contacts

Jun-hui Sun, MD,PH.D

Role: primary

1307005@zju.edu.cn

+86-0571-87236815

Tong-yin Zhu, MD

Role: backup

1513001@zju.edu.cn

+86-0571-87236812

Other Identifiers

HEPIC2004

Identifier Type: -

Identifier Source: org_study_id