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

BCLC Stage C Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992143
• Other study ID #: HEPIC2004
• Status: Recruiting
• Phase: Phase 2
• Start date: August 20, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Jun-hui Sun, MD,PH.D
• Phone: +86-0571-87236815
• Email: 1307005[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BCLC Stage C Hepatocellular Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year survival rate	1-year survival rate assessed by Kaplan-Meier analysis	at 1 year after enrolled
Secondary	Time to progression	Time to progression assessed by independent radiologic review according to mRECIST criteria	at 12 weeks and up to 2 years after enrolled
Secondary	Progression free survival	Progression free survival assessed by independent radiologic review according to mRECIST criteria	at 12 weeks and up to 2 years after enrolled
Secondary	Objective response rate	Objective response rate assessed by independent radiologic review according to mRECIST criteria	at 12 weeks and up to 2 years after enrolled
Secondary	Disease control rate	Disease control rate assessed by independent radiologic review according to mRECIST criteria	at 12 weeks and up to 2 years after enrolled