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Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC

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ClinicalTrials.gov Identifier: NCT03744247
Recruitment Status : Withdrawn (No paritcipants enrolled)
First Posted : November 16, 2018
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Kaiping Central Hospital
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 lenvatinib combined with PD-1 antibody compared with lenvtinib Alone in patients with advanced hepatocellular carcinoma (HCC)

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Lenvatinib Drug: PD-1 antibody Drug: Placebo Phase 3

Detailed Description:
Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and PD-1 antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared the efficacy and safety of lenvatinib plus PD-1 antibody and lenvatinib alone. Thus, the investigators carried out this prospective randomized control study to find out it.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Inhibitor Versus Lenvtinib Alone for Advanced Hepatocellular Carcinoma: a Multicentre Randomised Controlled Trial
Estimated Study Start Date : April 21, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lenvatinib Plus PD-1
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Drug: Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
Other Name: E7080, Lenvima

Drug: PD-1 antibody
3mg/kg intravenously every 2 weeks
Other Name: Programmed cell death 1 antibody

Active Comparator: Lenvatinib alone
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received placebo intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Drug: Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
Other Name: E7080, Lenvima

Drug: Placebo
Intravenously every 2 weeks




Primary 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.


Secondary 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 modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

  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 mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.

  3. Adverse Events [ Time Frame: 30 days ]
    Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

  4. Time to Progression (TTP) [ Time Frame: 12 months ]
    TTP was defined as the time from the date of randomization to the date of first documentation of disease progression based on mRECIST.



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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): NCT03744247


Locations
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China, Guangdong
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Guangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, China, 510620
Kaiping Central Hospital
Kaiping, Guangdong, China, 529300
China, Hunan
First Affiliated Hospital of University Of South China
Hengyang, Hunan, China, 421001
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Kaiping Central Hospital
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: NCT03744247     History of Changes
Other Study ID Numbers: HCC-renamed-S051
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: May 2, 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
Lenvatinib
PD-1 Antibody

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
Antibodies
Immunoglobulins
Lenvatinib
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action