Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC

December 3, 2019 updated by: Shi Ming, Sun Yat-sen University

Sorafenib Alone Versus Sorafenib Combined With Hepatic Arterial Chemoinfusion for Advanced HCC With Portal Vein Tumor Thrombosis: a Multicentre Randomised Controlled Trial

The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to find out it.

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Cancer Center Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510620
        • Guangzhou Twelfth People 's Hospita
      • Guangzhou, Guangdong, China, 510060
        • The First Affiliated Hospital of Sun Yat-sen University
      • Kaiping, Guangdong, China, 529300
        • The Kaiping Center's Hospital
    • Hunan
      • Hengyang, Hunan, China, 421001
        • First Affiliated Hospital of University of South China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
  • Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
  • portal vein tumor thrumbus confirmed in two image techniques
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • with no previous treatment
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Not amendable to surgical resection ,local ablative therapy and any other cured treatment.

  • The following laboratory parameters:

    • Platelet count ≥ 75,000/µL
    • Hemoglobin ≥ 8.5 g/dL
    • Total bilirubin ≤ 30mmol/L
    • Serum albumin ≥ 30 g/L
    • ASL and AST ≤ 5 x upper limit of normal
    • Serum creatinine ≤ 1.5 x upper limit of normal
    • INR ≤ 1.5 or PT/APTT within normal limits
    • Absolute neutrophil count (ANC) >1,500/mm3
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  • Known history of HIV
  • History of organ allograft
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Known central nervous system tumors including metastatic brain disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib combined with HAIC
Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
Procedure: Hepatic arterial infusion chemotherapy
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Names:
  • HAIC
Drug: Sorafenib
administration of Sorafenib
Drug: Folfox Protocol
Oxaliplatin , fluorouracil, and leucovorin
Other Names:
  • Oxaliplatin , fluorouracil, and leucovorin
Active Comparator: Sorafenib alone
Drug: Sorafenib
administration of Sorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 6 months
Overall survival
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 6 months
Time to progression
6 months
Adverse Events
Time Frame: 30 days
Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0
30 days
Number of of Patients developed Adverse Events
Time Frame: 30 days
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of University of South China
Guangzhou No.12 People's Hospital
Kaiping Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC-S021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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