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

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

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.

Study Overview

• Status: Recruiting
• Conditions: BCLC Stage C Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: TACE; Drug: Tilelizumab; Drug: Sorafenib

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tong-yin Zhu, MD; Phone Number: +86-0571-87236812; Email: 1513001@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Contact: Tong-yin Zhu, MD; Phone Number: +86-0571-87236812; Email: 1513001@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year survival rate	1-year survival rate assessed by Kaplan-Meier analysis	at 1 year after enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: BeiGene (Beijing) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: August 1, 2021
• First Submitted That Met QC Criteria: August 1, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Sorafenib; Transarterial Chemoembolization; BCLC Stage C; Tilelizumab
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: HEPIC2004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No