Phase II of Lenvatinib Plus PD-1 Antibody for Advanced HCC

NCT03746249 | Withdrawn Phase 2 DMC

• 1 other identifier: HCC-S052
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody in patients with advanced hepatocellular carcinoma (HCC)

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Lenvatinib; PD-1 Antibody

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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.

  12 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  12 months

• Overall Survival (OS)

  12 months

• Time to Progression (TTP)

  12 months

• Adverse Events

  30 days

Study Arms (1)

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

Interventions

Lenvatinib DRUG

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

Also known as: E7080, Lenvima

Lenvatinib Plus PD-1

PD-1 antibody DRUG

3mg/kg intravenously every 2 weeks

Also known as: Programmed cell death 1 antibody

Lenvatinib Plus PD-1

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

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, 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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: December 17, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

CN (1)