NCT03722498

Brief Summary

To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)

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 Jun 2018

Geographic Reach
1 country

3 active sites

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withdrawn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

Study Start

First participant enrolled

June 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2021

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

October 25, 2018

Last Update Submit

July 9, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Hepatic arterial infusion chemotherapySorafenib

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death

    12 months

Secondary Outcomes (3)

  • Overall survival

    12 months

  • Adverse Events

    30 Days after HAIC and TACE

  • Objective response rate

    12 months

Study Arms (2)

HAIC of FOLFOX

EXPERIMENTAL

Hepatic arterial infusion chemotherapy with oxaliplatin, leucovorin, and 5-fluorouracil

Drug: HAIC of FOLFOX

Sorafenib

ACTIVE COMPARATOR

Sorafenib 400 mg orally twice a day

Drug: Sorafenib

Interventions

HAIC of FOLFOXDRUG

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

Also known as: Oxaliplatin , fluorouracil, and leucovorin
HAIC of FOLFOX
SorafenibDRUG

administration of Sorafenib

Sorafenib

Eligibility Criteria

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

You may qualify if:

  • TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;
  • Except for TACE, patients have received no previous anti-tumor treatment;
  • The diagnosis of HCC was based on histological results;
  • Patients must have at least one tumor lesion that can be accurately measured;
  • Not amendable to surgical resection ,local ablative therapy and any other cured treatment;
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only;
  • No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 5 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) 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;
  • 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 (3)

Guangzhou Twelfth People 's Hospital

Guangzhou, Guangdong, 510620, China

Location

Ming Shi

Guangzhou, Guangdong, China

Location

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

OxaliplatinFluorouracilLeucovorinSorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesPhenylurea CompoundsUreaAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicPyridines

Study Officials

  • Ming Shi, MD

    The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Study Start

June 1, 2018

Primary Completion

March 22, 2021

Study Completion

March 22, 2021

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations

CN(3)