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Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC

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ClinicalTrials.gov Identifier: NCT02774187
Recruitment Status : Active, not recruiting
First Posted : May 17, 2016
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Dongguan People's Hospital
Kaiping Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
Guangzhou No.12 People's Hospital
The First Affiliated Hospital of University of South China
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Sorafenib Procedure: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sorafenib Alone Versus Sorafenib Combined With Hepatic Arterial Chemoinfusion for Advanced HCC With Portal Vein Tumor Thrombosis: a Multicentre Randomised Controlled Trial
Actual Study Start Date : May 2016
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sorafenib combined with HAIC
Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
Drug: Sorafenib
administration of Sorafenib

Procedure: Hepatic arterial infusion chemotherapy
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Name: HAIC

Drug: Folfox Protocol
Oxaliplatin , fluorouracil, and leucovorin
Other Name: Oxaliplatin , fluorouracil, and leucovorin

Active Comparator: Sorafenib alone
Sorafenib alone
Drug: Sorafenib
administration of Sorafenib




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months ]
    Overall survival


Secondary Outcome Measures :
  1. Time to progression [ Time Frame: 6 months ]
    Time to progression

  2. Adverse Events [ Time Frame: 30 days ]
    Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0

  3. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774187


Locations
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China, Guangdong
Dongguan People 's Hospital
Dongguan, Guangdong, China, 523059
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Guangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, China, 510620
The Kaiping Center's Hospital
Kaiping, Guangdong, China, 529300
China, Hunan
First Affiliated Hospital of University Of South China
Hengyang, Hunan, China, 421001
China, Shanxi
First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shanxi, China, 710061
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Dongguan People's Hospital
Kaiping Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
Guangzhou No.12 People's Hospital
The First Affiliated Hospital of University of South China
Investigators
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Principal Investigator: Ming Shi, MD The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shi Ming, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02774187     History of Changes
Other Study ID Numbers: HCC-S021
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by Shi Ming, Sun Yat-sen University:
Hepatocellular Carcinoma
Hepatic arterial infusion chemotherapy
Sorafenib
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Oxaliplatin
Fluorouracil
Sorafenib
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors