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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Hepatocellular Carcinoma; Portal Vein Thrombosis
• Intervention / Treatment: Radiation: SBRT+TACE+Sorafenib; Drug: Sorafenib

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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tan-yang Zhou, MD,PH.D; Phone Number: +86-0571-87236812; Email: zhoutanyang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Contact: Tan-yang Zhou, MD,PH.D; Phone Number: +86-0571-87236812; Email: zhoutanyang@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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT + TACE + Sorafenib; SBRT sequential TACE combined with Sorafenib	Radiation: SBRT+TACE+Sorafenib; SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later; Other Names: Stereotactic Body Radiation Therapy
Active Comparator: Sorafenib; Sorafenib 800 mg/day orally	Drug: Sorafenib; Sorafenib 800 mg/day orally; Other Names: Nexavar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 14, 2020

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,Portal Vein Tumor Thrombus; Radiation ,Sorafenib
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Embolism and Thrombosis; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: HEPIC2001

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