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

Phase 2

Recruiting

• Conditions: BCLC Stage C Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Drug: Tilelizumab; Drug: Sorafenib

• Registration Number: NCT04992143
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-01
• Study First Submitted QC: 2021-08-01
• Study First Posted: 2021-08-05
• Study Start: 2021-08-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-08-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
1-year survival rate	at 1 year after enrolled	1-year survival rate assessed by Kaplan-Meier analysis

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China