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

NCT03744247 | Withdrawn Phase 3 DMC

• 1 other identifier: HCC-renamed-S051
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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)

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Lenvatinib; PD-1 Antibody

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  12 months

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  12 months

• Objective Response Rate (ORR)

  12 months

• Adverse Events

  30 days

• Time to Progression (TTP)

  12 months

Study Arms (2)

Lenvatinib Plus PD-1

EXPERIMENTAL

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

Lenvatinib alone

ACTIVE COMPARATOR

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; Drug: Placebo

Interventions

Lenvatinib DRUG

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

Also known as: E7080, Lenvima

Lenvatinib Plus PD-1; Lenvatinib alone

PD-1 antibody DRUG

3mg/kg intravenously every 2 weeks

Also known as: Programmed cell death 1 antibody

Lenvatinib Plus PD-1

Placebo DRUG

Intravenously every 2 weeks

Lenvatinib alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Kaiping Central Hospital: collaborator
• Guangzhou No.12 People's Hospital: collaborator
• The First Affiliated Hospital of University of South China: collaborator

Study Sites (5)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, 510620, China

Location

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

Location

First Affiliated Hospital of University Of South China

Hengyang, Hunan, 421001, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib; spartalizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ming Shi, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: April 21, 2019
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 2, 2019

Record last verified: 2019-03

Locations

CN (5)