Back to resultsTACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC
Primary Purpose
BCLC Stage C Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TACE
Tilelizumab
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for BCLC Stage C Hepatocellular Carcinoma focused on measuring BCLC Stage C, Hepatocellular Carcinoma, Transarterial Chemoembolization, Sorafenib, Tilelizumab
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
Sites / Locations
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TACE combined Tilelizumab and Sorafenib
Arm Description
TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally)
Outcomes
Primary Outcome Measures
1-year survival rate
1-year survival rate assessed by Kaplan-Meier analysis
Secondary Outcome Measures
Time to progression
Time to progression assessed by independent radiologic review according to mRECIST criteria
Progression free survival
Progression free survival assessed by independent radiologic review according to mRECIST criteria
Objective response rate
Objective response rate assessed by independent radiologic review according to mRECIST criteria
Disease control rate
Disease control rate assessed by independent radiologic review according to mRECIST criteria
Full Information
NCT ID
NCT04992143
First Posted
August 1, 2021
Last Updated
February 14, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04992143
Brief Title
TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BCLC Stage C Hepatocellular Carcinoma
Keywords
BCLC Stage C, Hepatocellular Carcinoma, Transarterial Chemoembolization, Sorafenib, Tilelizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE combined Tilelizumab and Sorafenib
Arm Type
Experimental
Arm Description
TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally)
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
TACE first ,and more TACE could be performed when it is necessary.
Intervention Type
Drug
Intervention Name(s)
Tilelizumab
Intervention Description
Tilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Sorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE
Primary Outcome Measure Information:
Title
1-year survival rate
Description
1-year survival rate assessed by Kaplan-Meier analysis
Time Frame
at 1 year after enrolled
Secondary Outcome Measure Information:
Title
Time to progression
Description
Time to progression assessed by independent radiologic review according to mRECIST criteria
Time Frame
at 12 weeks and up to 2 years after enrolled
Title
Progression free survival
Description
Progression free survival assessed by independent radiologic review according to mRECIST criteria
Time Frame
at 12 weeks and up to 2 years after enrolled
Title
Objective response rate
Description
Objective response rate assessed by independent radiologic review according to mRECIST criteria
Time Frame
at 12 weeks and up to 2 years after enrolled
Title
Disease control rate
Description
Disease control rate assessed by independent radiologic review according to mRECIST criteria
Time Frame
at 12 weeks and up to 2 years after enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-hui Sun, MD,PH.D
Phone
+86-0571-87236815
Email
1307005@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Tong-yin Zhu, MD
Phone
+86-0571-87236812
Email
1513001@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-hui Sun, MD,PH.D
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-hui Sun, MD,PH.D
Phone
+86-0571-87236815
Email
1307005@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Tong-yin Zhu, MD
Phone
+86-0571-87236812
Email
1513001@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC
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