NCT03919383

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 3, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

April 15, 2019

Last Update Submit

May 30, 2019

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaLenvatinibToripalimab

Outcome Measures

Primary Outcomes (1)

  • 6 months progression free survival rates

    Progression was defined as progressive disease by independent radiologic review according to RECIST, version 1.1, criteria or death from any cause.

    6 months

Secondary Outcomes (4)

  • Progression Free Survival (PFS)

    6 months

  • Overall Survival (OS)

    6 months

  • Objective Response Rate (ORR)

    6 months

  • Adverse Events

    6 months

Study Arms (1)

Lenvatinib Plus Toripalimab

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 21-day treatment cycles, and received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Drug: LenvatinibDrug: Toripalimab

Interventions

LenvatinibDRUG

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

Lenvatinib Plus Toripalimab
ToripalimabDRUG

240mg intravenously every 3 weeks

Lenvatinib Plus Toripalimab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 systemic 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinibtoripalimab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases
0

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

April 15, 2019

First Posted

April 18, 2019

Study Start

April 15, 2019

Primary Completion

December 1, 2019

Study Completion

December 31, 2019

Last Updated

June 3, 2019

Record last verified: 2019-04

Locations

CN(1)