SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT

Unresectable Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387695
• Other study ID #: HEPIC2001
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Portal Vein Thrombosis
• Thrombosis
• Unresectable Hepatocellular Carcinoma

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