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HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC

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ClinicalTrials.gov Identifier: NCT02856126
Recruitment Status : Unknown
Verified December 2019 by Shi Ming, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : August 4, 2016
Last Update Posted : December 10, 2019
Sponsor:
Collaborators:
Kaiping Central Hospital
First Affiliated Hospital, Sun Yat-Sen University
Dongguan People's 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 hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Hepatic arterial infusion chemotherapy Procedure: Transarterial chemoembolization Drug: TACE regimen Drug: HAIC Regimen Drug: Oral Sorafenib Phase 3

Detailed Description:
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C HCC. Thus, the investigators carried out this prospective randomized control study to find out it.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Plus Sorafenib Compared With Transarterial Chemoembolization Plus Sorafenib in Patients With BCLC C Stage Hepatocellular Carcinoma
Study Start Date : August 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arm Intervention/treatment
Experimental: HAIC plus sorafenib
Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib
Procedure: Hepatic arterial infusion chemotherapy
Drug: HAIC Regimen
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin

Drug: Oral Sorafenib
Oral Sorafenib, 400mg, Bid

Active Comparator: TACE plus sorafenib
Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
Procedure: Transarterial chemoembolization
Drug: TACE regimen
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)

Drug: Oral Sorafenib
Oral Sorafenib, 400mg, Bid




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 18 months ]
    Overall survival


Secondary Outcome Measures :
  1. Progress free survival [ Time Frame: 18 months ]
    Progress free survival

  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



Information from the National Library of Medicine

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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 BCLC C stage 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.
  • 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:

  • Main portal vein occlusion
  • 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.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
  • Serious non-healing wound, ulcer, or bone fracture
  • 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): NCT02856126


Contacts
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Contact: Ming Shi, MD (8620)-87343938 shiming@sysu.edu.cn
Contact: Rongping Guo, MD (8620)-87342266 guorp@sysucc.org.cn

Locations
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China, Guangdong
Dongguan People's Hospital Recruiting
Dongguan, Guangdong, China, 523059
Contact: Wusheng Yu, MD    13827285010    yuwusheng1998@126.com   
Cancer Center Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ming Shi, MD    8620-87343115    shiming@mail.sysu.edu.cn   
The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Guosheng Tan, MD    13725254145    tgs1976@163.com   
Guangzhou Twelfth People 's Hospital Recruiting
Guangzhou, Guangdong, China, 510620
Contact: Yuanmin Zhou, MD    15521278919    13430288977@139.com   
Principal Investigator: Jinghua Chen, MD         
Kaiping Central Hospital Recruiting
Kaiping, Guangdong, China, 529300
Contact: Shijie Zhang, MD    13717287622    Shijie_9262511@163.com   
China, Hunan
The First Affiliated Hospital of University Of South China Recruiting
Hengyang, Hunan, China, 421001
Contact: Xiaoping Wu, MD    13975486015    wxp19730806@sina.com   
China, Shanxi
The First Affiliated Hospital Of Xi'an Jiaotong University Recruiting
Xi'an, Shanxi, China, 710061
Contact: Xin Zheng, MD    13649265446    183421344@qq.com   
Sponsors and Collaborators
Sun Yat-sen University
Kaiping Central Hospital
First Affiliated Hospital, Sun Yat-Sen University
Dongguan People's 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
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Responsible Party: Shi Ming, Proffessor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02856126    
Other Study ID Numbers: HCC-S022
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shi Ming, Sun Yat-sen University:
Hepatic arterial infusion chemotherapy
Transarterial Chemoembolization
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
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action