NCT03775395

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with lenvatinib combined with HAIC in patients with advanced hepatocellular carcinoma (HCC)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P50-P75 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

December 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 3, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

December 12, 2018

Last Update Submit

January 1, 2019

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaHepatic artery infusion chemotherapySorafenibLenvatinib

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival

    Time Frame: 12 months

Secondary Outcomes (3)

  • Time to progression

    Time Frame: 12 months

  • Adverse Events

    [Time Frame: 30 days]

  • Progression Free Survival (PFS)

    Time Frame: 12 months

Study Arms (2)

HAIC plus Lenvatinib

EXPERIMENTAL
Drug: LenvatinibProcedure: Hepatic arterial infusion chemotherapy

HAIC plus Sorafenib

ACTIVE COMPARATOR
Drug: SorafenibProcedure: Hepatic arterial infusion chemotherapy

Interventions

LenvatinibDRUG

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

HAIC plus Lenvatinib
SorafenibDRUG

400mg BID daily oral dosing

HAIC plus Sorafenib
Hepatic arterial infusion chemotherapyPROCEDURE

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

HAIC plus LenvatinibHAIC plus Sorafenib

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:
  • 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
  • +2 more criteria

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

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinibSorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Ming Shi, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Shi, MD

CONTACT

+862087343938shiming@sysucc.org.cn

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
Clinical Professor

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 13, 2018

Study Start

December 12, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 3, 2019

Record last verified: 2019-01

Locations

CN(1)