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HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775395
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : January 3, 2019
Sponsor:
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 lenvatinib combined with HAIC in patients with advanced hepatocellular carcinoma (HCC)

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hepatic Artery Infusion Chemotherapy Plus Lenvatinib vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HAIC plus Lenvatinib Drug: Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.

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

Active Comparator: HAIC plus Sorafenib Drug: Sorafenib
400mg BID daily oral dosing

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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Time Frame: 12 months ]
    Overall survival


Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Time Frame: 12 months ]
    Time to progression

  2. Adverse Events [ Time Frame: [Time Frame: 30 days] ]
  3. Progression Free Survival (PFS) [ Time Frame: Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • Barcelona clinic liver cancer-stage C
  • 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): NCT03775395


Contacts
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Contact: Ming Shi, MD +862087343938 shiming@sysucc.org.cn

Locations
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China, Guangdong
Cancer Center Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ming Shi, MD    8620-87343115    shiming@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Ming Shi, MD Sun Yat-sen University
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Responsible Party: Shi Ming, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03775395    
Other Study ID Numbers: HCC-S055
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shi Ming, Sun Yat-sen University:
Hepatocellular carcinoma
Hepatic artery infusion chemotherapy
Sorafenib
Lenvatinib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action