NCT04044313

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with advanced hepatocellular carcinoma (HCC)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

August 1, 2019

Last Update Submit

June 8, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaHepatic artery infusion chemotherapyOxaliplatin, 5-Fluorouracil and LeucovorinLenvatinibToripalimab

Outcome Measures

Primary Outcomes (1)

  • Progression free survival rate at 6 months

    Progression was defined as progressive disease by independent radiologic review according to RECIST or death from any cause

    6 months

Secondary Outcomes (4)

  • Overall survival (OS)

    6 months

  • Progression free survival (PFS)

    6 months

  • Objective response rate (ORR)

    6 months

  • Adverse events

    6 months

Study Arms (1)

HAIC plus Lenvatinib and Toripalimab

EXPERIMENTAL

Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 240mg intravenously every 3 weeks.

Procedure: Hepatic arterial infusion chemotherapyDrug: LenvatinibDrug: Toripalimab

Interventions

Hepatic arterial infusion chemotherapyPROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

HAIC plus Lenvatinib and Toripalimab
LenvatinibDRUG

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

HAIC plus Lenvatinib and Toripalimab
ToripalimabDRUG

240mg intravenously every 3 weeks

HAIC plus Lenvatinib and 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 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:
  • Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 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

Related Links

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

August 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 28, 2022

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

CN(1)