NCT05121571

Brief Summary

Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with sorafenib who showed TACE-resistant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable hepatocellular-carcinoma

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

Study Start

First participant enrolled

April 21, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

2.6 years

First QC Date

November 14, 2021

Last Update Submit

November 16, 2021

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaTACE failureSorafenibHepatic arterial infusion chemotherapyOxaliplatin, fluorouracil, and leucovorin

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    12 months

Secondary Outcomes (3)

  • Number of Adverse Events

    30 days

  • overall survival

    24 months

  • tumor response

    6 months

Study Arms (2)

HAIC of FOLFOX

EXPERIMENTAL

Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin

Procedure: HAIC

Sorafenib

ACTIVE COMPARATOR
Drug: Sorafenib

Interventions

HAICPROCEDURE

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

HAIC of FOLFOX
SorafenibDRUG

sorafenib 400mg bid

Sorafenib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria
  • TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria
  • Without extrahepatic metastasis
  • The following laboratory parameters:
  • Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 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

You may not qualify if:

  • Known history of HIV
  • History of organ allograft
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Serious non-healing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis.
  • Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • Huang Y, Zhang L, He M, Lai Z, Bu X, Wen D, Li Q, Xu L, Wei W, Zhang Y, Zhou Z, Chen M, Guo R, Shi M, Kan A. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Sorafenib for Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization: Retrospective Subgroup Analysis of 2 Prospective Trials. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221117389. doi: 10.1177/15330338221117389.

    PMID: 36529949DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

November 14, 2021

First Posted

November 16, 2021

Study Start

April 21, 2016

Primary Completion

December 12, 2018

Study Completion

May 1, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations

CN(1)