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

NCT ID: NCT03744247

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-21
• Study Completion Date: 2021-06-01

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)

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

12 mg (or 8 mg) once daily (QD) oral dosing.

PD-1 antibody

Intervention Type: DRUG

3mg/kg intravenously every 2 weeks

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.

Group Type: ACTIVE_COMPARATOR

Lenvatinib

Intervention Type: DRUG

12 mg (or 8 mg) once daily (QD) oral dosing.

Placebo

Intervention Type: DRUG

Intravenously every 2 weeks

Interventions

Lenvatinib

12 mg (or 8 mg) once daily (QD) oral dosing.

Intervention Type: DRUG

PD-1 antibody

3mg/kg intravenously every 2 weeks

Intervention Type: DRUG

Placebo

Intravenously every 2 weeks

Intervention Type: DRUG

Other Intervention Names

E7080, Lenvima; Programmed cell death 1 antibody

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Kaiping Central Hospital

OTHER

Sponsor Role: collaborator

Guangzhou No.12 People's Hospital

OTHER_GOV

Sponsor Role: collaborator

The First Affiliated Hospital of University of South China

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Shi Ming

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Shi, MD

Role: PRINCIPAL_INVESTIGATOR

The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, China

Kaiping Central Hospital

Kaiping, Guangdong, China

First Affiliated Hospital of University Of South China

Hengyang, Hunan, China

Countries

China

Other Identifiers

HCC-renamed-S051

Identifier Type: -

Identifier Source: org_study_id