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Recruiting NCT05476432

HAIC With One-day FOLFOX vs. HAIC With Two-day FOLFOX for Unresectable HCC: a Non-inferiority Study

Phase III Interventional Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HAIC, FOLFOX 2d, FOLFOX 1d.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Hepatic Arterial Infusion With Oxaliplatin & 23h Fluorouracil Versus Hepatic Arterial Infusion With Oxaliplatin & 46h Fluorouracil for Unresectable Hepatocellular Carcinoma：a Non-inferiority Study

Overview

Hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin\&5-fluorouracil was effective in unresectable hepatocellular carcinoma (HCC). The program of FOLFOX-HAIC in HCC was performed for 1 day (HAIC 1d) or 2 days (HAIC 2d). We hereby retrospectively compared the efficacy and safety between these two treatment regimens, and explored the predictive power of thymidylate synthase (TYMS), an enzyme involved in the DNA synthesis process and metabolism of fluorouracil. Patients with HCC staged BCLC A-B receive HAIC only, and patients with HCC staged BCLC C receive HAIC plus systemic treatment, such as sorafenib, A+T, lenvatinib.

Interventions

  • Procedure HAIC
    The microcatheter was advanced into the hepatic artery, and patients were transferred to the inpatient ward for drug infusion via the hepatic artery
  • Drug FOLFOX 2d
    Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 46 hours
  • Drug FOLFOX 1d
    Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 23 hours

Primary outcome measures

  • Overall survival [Time frame: 24 months]
Secondary outcome measures (4)
  • Progression-free survival [Time frame: 12 months]
  • objective response rate per RECIST 1.1 [Time frame: 12 months]
  • Adverse Events [Time frame: 30 days]
  • the predictive power of thymidylate synthase (TYMS) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Age range from 18-75 years;
  • KPS≥70;
  • The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A, BCLC B or BCLC C based on Barcelona Clinic Liver Cancer staging system.
  • Patients must have at least one tumor lesion that can be accurately measured
  • Diagnosed as unresectable with consensus by the panel of liver surgery experts
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • 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 ≤ 6 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.

Exclusion criteria

  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • 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.
  • Evidence of bleeding diathesis.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
  • Serious non-healing wound, ulcer, or bone fracture
  • Known central nervous system tumors including metastatic brain disease
  • Poor compliance that can not comply with the course of treatment and follow up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • The First People's Hospital of Foshan — Foshan
  • Cancer Center Sun Yat-sen University — Guangzhou
  • Guangzhou Twelfth People 's Hospita — Guangzhou

Identifiers

NCT: NCT05476432 · SH-5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗