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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Recruitment Status : Withdrawn (Protocol modification)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

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody for Intermediate-stage Hepatocellular Carcinoma Beyond Up-to-seven Criteria
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

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.

Drug: PD-1 antibody
3mg/kg 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: 12 months ]
    Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT03775707

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China, Guangdong
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Shi Ming
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Responsible Party: Shi Ming, Proffessor, Sun Yat-sen University Identifier: NCT03775707    
Other Study ID Numbers: HCC-S063
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: December 2018

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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
PD-1 Antibody
BCLC B stage
Beyond up-to-seven criteria
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action