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Lenvatinib Plus PD-1 Antibody for Intermediate-stage HCC Beyond Up-to-seven Criteria

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. Read our disclaimer for details. Identifier: NCT03775707
Recruitment Status : Withdrawn (Protocol modification)
First Posted : December 14, 2018
Last Update Posted : May 6, 2019
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 14, 2018
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
  • 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.
  • 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.
  • Adverse Events [ Time Frame: 12 months ]
    Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Lenvatinib Plus PD-1 Antibody for Intermediate-stage HCC Beyond Up-to-seven Criteria
Official Title  ICMJE Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody for Intermediate-stage Hepatocellular Carcinoma Beyond Up-to-seven Criteria
Brief Summary The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria
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 evaluated the efficacy and safety of lenvatinib plus PD-1 antibody. Thus, the investigators carried out this prospective study to find out it.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Lenvatinib
    12 mg (or 8 mg) once daily (QD) oral dosing.
  • Drug: PD-1 antibody
    3mg/kg intravenously every 2 weeks
Study Arms  ICMJE 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
  • Drug: PD-1 antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 2, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2018)
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 B
  • Beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor [in cm] and the number of tumors)
  • Eastern Cooperative Oncology Group performance status of 0 to 1
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03775707
Other Study ID Numbers  ICMJE HCC-S063
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shi Ming, Sun Yat-sen University
Study Sponsor  ICMJE Shi Ming
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP