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HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC

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ClinicalTrials.gov Identifier: NCT03780634
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : December 19, 2018
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
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 artery infusion chemotherapy (HAIC) combined with Programmed Cell Death Protein-1 (PD-1) antibody compared with HAIC plus sorafenib in patients with advanced hepatocellular carcinoma (HCC)

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: HAIC Drug: PD-1 antibody Drug: Sorafenib Phase 2

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 hepatocellular (HCC). Programmed Cell Death Protein-1 (PD-1) antibody has been proved effective and safety for advanced HCC. There is no study about HAIC plus PD-1 antibody. Thus, the investigators carried out this prospective randomized control study to compare HAIC plus sorafenib and HAIC plus PD-1 antibody.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Artery Infusion Chemotherapy Plus Programmed Cell Death Protein-1 (PD-1) Antibody vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HAIC plus PD-1 antibody
Participants received PD-1 antibody intravenously and hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Procedure: HAIC
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

Drug: PD-1 antibody
200mg intravenously every 3 weeks
Other Name: Programmed cell death 1 antibody

Active Comparator: HAIC plus sorafenib
Participants received sorafenib capsules 400mg bid in continuous 21-day treatment cycles, and received hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Procedure: HAIC
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

Drug: Sorafenib
400 mg Bid Po




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 12 months ]
    PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), or date of death, whichever occurred first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 12 months ]
    OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

  2. Objective Response Rate (ORR) [ Time Frame: 12 months ]
    ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST.

  3. Adverse Events [ Time Frame: 12 months ]
    Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03



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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
  • Major portal vein tumor thrombus (Vp3,Vp4)
  • Eastern Cooperative Oncology Group performance status of 0 to 1
  • 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): NCT03780634


Locations
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China, Guangdong
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China, 510620
Kaiping Central Hospital
Kaiping, Guangdong, China, 529300
Sponsors and Collaborators
Sun Yat-sen University
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Investigators
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Principal Investigator: Ming Shi, MD Sun Yat-sen University

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Responsible Party: Shi Ming, Proffessor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03780634     History of Changes
Other Study ID Numbers: HCC-S059
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: March 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 arterial infusion chemotherapy
Programmed cell death protein-1 antibody
Oxaliplatin, 5-Fluorouracil and Leucovorin

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
Sorafenib
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Protein Kinase Inhibitors
Enzyme Inhibitors