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HAIC Using Oxaliplatin Plus Fluorouracil/Leucovorin for Patients With Locally Advanced HCC

NCT02436044 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2019-08-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

HAIC using oxaliplatin plus fluorouracil/leucovorin

Hepatic arterial infusion chemotherapy using oxaliplatin plus fluorouracil/leucovorin

DRUG

Oxaliplatin

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

DRUG

Fluorouracil

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

DRUG

Leucovorin

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

Sponsors & Collaborators

  • Ming Zhao

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02436044 on ClinicalTrials.gov