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Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE

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: NCT03722498
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
Guangzhou No.12 People's Hospital
Kaiping Central Hospital
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

Study Description
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Brief Summary:
To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: HAIC of FOLFOX Drug: Sorafenib Phase 2

Detailed Description:

In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months.

Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 22, 2021
Estimated Study Completion Date : March 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HAIC of FOLFOX
Hepatic arterial infusion chemotherapy with oxaliplatin, leucovorin, and 5-fluorouracil
 Drug: HAIC of FOLFOX
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Name: Oxaliplatin , fluorouracil, and leucovorin
Active Comparator: Sorafenib
Sorafenib 400 mg orally twice a day
 Drug: Sorafenib
administration of Sorafenib


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]
    The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months ]
    The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death

  2. Adverse Events [ Time Frame: 30 Days after HAIC and TACE ]
    Postoperative adverse events were graded based on CTCAE v4.03

  3. Objective response rate [ Time Frame: 12 months ]
    Best response based on mRECIST


Eligibility Criteria
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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:

  • TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;
  • Except for TACE, patients have received no previous anti-tumor treatment;
  • The diagnosis of HCC was based on histological results;
  • Patients must have at least one tumor lesion that can be accurately measured;
  • Not amendable to surgical resection ,local ablative therapy and any other cured treatment;
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only;
  • No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 5 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) 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;
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
Contacts and Locations
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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): NCT03722498


Contacts
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Contact: Ming Shi, MD (8620)-87343938 shiming@sysu.edu.cn

Locations
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China, Guangdong
Guangzhou Twelfth People 's Hospital Recruiting
Guangzhou, Guangdong, China, 510620
Contact: Yuanmin Zhou, MD    15521278919    13430288977@139.com   
Principal Investigator: Jinghua Chen, MD         
Ming Shi Recruiting
Guangzhou, Guangdong, China
Contact: Ming Shi, MD    (8620)-87343938    shiming@sysu.edu.cn   
Principal Investigator: Ming Shi, MD         
Kaiping Central Hospital Recruiting
Kaiping, Guangdong, China, 529300
Contact: Shijie Zhang, MD    13717287622    Shijie_9262511@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Guangzhou No.12 People's Hospital
Kaiping Central Hospital
Investigators
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Principal Investigator: Ming Shi, MD The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
More Information
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Responsible Party: Shi Ming, Proffesor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03722498    
Other Study ID Numbers: HCC-H171011
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Hepatic arterial infusion chemotherapy
Sorafenib
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
Leucovorin
Fluorouracil
Oxaliplatin
Sorafenib
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Protein Kinase Inhibitors
Enzyme Inhibitors