NCT02436044

Brief Summary

A large proportion of Asian patients with HCC present with locally advanced or metastatic disease,at which point they are ineligible for curative treatments.Oxaliplatin plus fluorouracil/leucovorin intravenous infusion was proved effective in prolonging progression-free survival(PFS) than doxorubicin as palliative chemotherapy in patients with advanced HCC from Asia. Besides, hepatic arterial infusion chemotherapy (HAIC）is a widely used method for primary or metastasis liver tumor with high local tumor response. To our knowledge, there have not been any prospective studies to assess the safety and effecacy of HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.Thus,the purpose of this phase 2 study was to assess the safety and effecacy of HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.

Trial Health

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Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

First QC Date

May 3, 2015

Last Update Submit

August 16, 2019

Conditions

Hepatocellular CarcinomaInjury; Blood Vessel, Hepatic, Artery

Keywords

Hepatocellular CarcinomaLocally advanced stgeHAICFOLFOX4Locally advanced

Interventions

HAIC using oxaliplatin plus fluorouracil/leucovorinPROCEDURE

Hepatic arterial infusion chemotherapy using oxaliplatin plus fluorouracil/leucovorin

OxaliplatinDRUG

Oxaliplatin, 130mg/m2, intraarterial infusion for 2 hours, on day 1,every 3 weeks

FluorouracilDRUG

Fluorouracil, 1-st.400mg/m2, bolus injection, on day 1,every 3 weeks 2-nd.2400mg/m2, intraarterial infusion for 46 hours, on day 1-2,every 3 weeks

LeucovorinDRUG

Leucovorin, 200mg/m2, intraarterial infusion for 2 hours, on day 1,every 3 weeks

Eligibility Criteria

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

You may qualify if:

  • No extrahepatic spread on imaging, and filfill one of them as follows: 1.multiple HCC lesions,\> 5.0 cm in diameter;2.Portal venous hepatic vein/tumor thrombus or arteriovenous/portal fistula;3.Direct invasion adjacent organs except gallbladder or penetrate the peritoneum;4.diffuse HCC.
  • Eastern Cooperative Oncology Group Performance Status 0-2
  • Child-Pugh Stage A or B
  • At least one evaluable intrahepatic target lesions
  • Previous accept sorafenib but stoped for more than 4 weeks because of disease progression or intolerance to sorafenib or refused to recieved sorafenib
  • Stoped for more than 4 weeks after local treatments(surgical resection, radiofrequency ablation, transcatheter arterial chemoembolization) of tumor if presence
  • Sign the informed consent.

You may not qualify if:

  • Ever received oxaliplatin or fluorouracil/leucovorin;
  • A platelet counts of \> 60,000/mm3, prothrombin time activity \<40%;
  • Albumin \<2.8 g/dL, total bilirubin ≥51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）≥5 times of upper limit
  • Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;
  • Severe heart, brain or kidney diseases
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC
  • Pregnant women or lactating women;
  • Allergy to fluorouracil, oxaliplatin, leucovorin calcium or iodine contrast agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 500060, China

Location

Related Publications (1)

  • Liu S, Lai J, Lyu N, Xie Q, Cao H, Chen D, He M, Zhang B, Zhao M. Effects of Antiviral Therapy on HBV Reactivation and Survival in Hepatocellular Carcinoma Patients Undergoing Hepatic Artery Infusion Chemotherapy. Front Oncol. 2021 Feb 1;10:582504. doi: 10.3389/fonc.2020.582504. eCollection 2020.

    PMID: 33614477DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularWounds and Injuries

Interventions

FluorouracilLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician in Minimally Invasive Interventional Division,Medical Imaging Center,Sun Yat-sen University Cancer Center

Study Record Dates

First Submitted

May 3, 2015

First Posted

May 6, 2015

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

CN(1)