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Sorafenib or Lenvatinib Plus HAIC of 130 mg/m² Oxaliplatin, and 5-fu vs Sorafenib or Lenvatinib Plus HAIC of 85mg/m² Oxaliplatin, and 5-fu for Unresectable Advanced HCC: a Randomised Phase 3 Trial

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ClinicalTrials.gov Identifier: NCT04687163
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : January 13, 2021
Sponsor:
Collaborators:
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

Study Description
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Brief Summary:
A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: HAIC of 130 mg/m² Oxaliplatin, and 5-fu Drug: HAIC of 85 mg/m² Oxaliplatin, and 5-fu Drug: TKI Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 130 mg/m² Oxaliplatin, Leucovorin, and Fluorouracil Versus Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 85 mg/m² Oxaliplatin, Leucovorin, and 1200 mg/m² Fluorouracil for Unresectable Advanced Hepatocellular Carcinoma: a Randomised Phase 3 Trial
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OXA 130
Patients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu
 Drug: HAIC of 130 mg/m² Oxaliplatin, and 5-fu
Hepatic arterial infusion of 130 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU

Drug: TKI
sorafenib 400mg bid or lenvatinib 12 mg/day (for bodyweight ≥60 kg) or 8 mg/day (for bodyweight <60 kg)
Active Comparator: OXA 85
Patients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu
 Drug: HAIC of 85 mg/m² Oxaliplatin, and 5-fu
Hepatic arterial infusion of 85 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU

Drug: TKI
sorafenib 400mg bid or lenvatinib 12 mg/day (for bodyweight ≥60 kg) or 8 mg/day (for bodyweight <60 kg)


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 24 months ]
  2. objective response rate [ Time Frame: 6 months ]
  3. time to response [ Time Frame: 12 months ]
    time to the date that patients achieved objective response

  4. Adverse Events [ Time Frame: 30 Days after HAIC ]

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:

  • KPS≥70;
  • 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;
  • With vascular invasion or extrahepatic metastasis
  • Diagnosed as unresectable with consensus by the panel of liver surgery experts;
  • No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only

  • 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 ≤ 6 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:

  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • 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.
  • Evidence of bleeding diathesis.
  • 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): NCT04687163


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   
Guangzhou Twelfth People 's Hospita Recruiting
Guangzhou, Guangdong, China, 510620
Contact: Yuanmin Zhou, MD    15521278919    13430288977@139.com   
Principal Investigator: YuanMin Zhou, 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
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
More Information
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Responsible Party: Shi Ming, Proffessor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04687163    
Other Study ID Numbers: SH-3
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs