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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04387695
Other study ID # HEPIC2001
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 30, 2020
Est. completion date August 1, 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
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 ?a-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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
SBRT+TACE+Sorafenib
SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later
Drug:
Sorafenib
Sorafenib 800 mg/day orally

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 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. at 12 weeks after randomization
Secondary 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. at 12 weeks after randomization
Secondary Overall patient survival rate The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons. up to 2 years after randomization
Secondary 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. at 12 weeks and up to 2 years after randomization
Secondary 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. at 12 weeks and up to 2 years after randomization
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