Back to resultsSBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
Primary Purpose
Unresectable Hepatocellular Carcinoma, Portal Vein Thrombosis
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SBRT+TACE+Sorafenib
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma,Portal Vein Tumor Thrombus, Radiation ,Sorafenib
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Child-Pugh score ≤ 7
- Performance status: ECOG score ≤ 2
- HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
- the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
- No previous therapy for HCC
- at least one measurable target lesion according to RECIST 1.1
- Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
- Serum total bilirubin ≤ 2 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
- Creatinine ≤ 1.5 x ULN
- No plan for pregnancy or breast feeding. Active contraception.
- Willing to give informed consent
Exclusion Criteria:
- Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- Complete obstruction of hepatic outflow
- Uncontrolled ascites of hepatic encephalopathy
- Prior liver transplantation
- Positive for human immunodeficiency virus (HIV)
- Active gastric or duodenal ulcer
- Other uncontrolled comorbidities or malignancy
- Inability to give informed consent
Sites / Locations
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SBRT + TACE + Sorafenib
Sorafenib
Arm Description
SBRT sequential TACE combined with Sorafenib
Sorafenib 800 mg/day orally
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) rate
Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
Secondary Outcome Measures
Radiologic response rate
Radiologic response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Overall patient survival rate
The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Objective response rate
Objective response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Disease control rate
Disease control rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Full Information
NCT ID
NCT04387695
First Posted
May 11, 2020
Last Updated
February 14, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04387695
Brief Title
SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
Official Title
SBRT Sequential TACE Combined With Sorafenib Versus Sorafenib Alone in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus：A Single-center Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 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
To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
Detailed Description
HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Hepatocellular Carcinoma, Portal Vein Thrombosis
Keywords
Hepatocellular Carcinoma,Portal Vein Tumor Thrombus, Radiation ,Sorafenib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBRT + TACE + Sorafenib
Arm Type
Experimental
Arm Description
SBRT sequential TACE combined with Sorafenib
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Sorafenib 800 mg/day orally
Intervention Type
Radiation
Intervention Name(s)
SBRT+TACE+Sorafenib
Other Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
Sorafenib 800 mg/day orally
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) rate
Description
Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
Time Frame
at 12 weeks after randomization
Secondary Outcome Measure Information:
Title
Radiologic response rate
Description
Radiologic response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Time Frame
at 12 weeks after randomization
Title
Overall patient survival rate
Description
The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Time Frame
up to 2 years after randomization
Title
Objective response rate
Description
Objective response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Time Frame
at 12 weeks and up to 2 years after randomization
Title
Disease control rate
Description
Disease control rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Time Frame
at 12 weeks and up to 2 years after randomization
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
Performance status: ECOG score ≤ 2
HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
No previous therapy for HCC
at least one measurable target lesion according to RECIST 1.1
Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
Serum total bilirubin ≤ 2 x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
Creatinine ≤ 1.5 x ULN
No plan for pregnancy or breast feeding. Active contraception.
Willing to give informed consent
Exclusion Criteria:
Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
Complete obstruction of hepatic outflow
Uncontrolled ascites of hepatic encephalopathy
Prior liver transplantation
Positive for human immunodeficiency virus (HIV)
Active gastric or duodenal ulcer
Other uncontrolled comorbidities or malignancy
Inability to give informed consent
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
Tan-yang Zhou, MD,PH.D
Phone
+86-0571-87236812
Email
zhoutanyang@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
Tan-yang Zhou, MD,PH.D
Phone
+86-0571-87236812
Email
zhoutanyang@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
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