Comparing one-day and two-day chemotherapy for unresectable liver cancer
Hepatic Arterial Infusion With Oxaliplatin & 23h Fluorouracil Versus Hepatic Arterial Infusion With Oxaliplatin & 46h Fluorouracil for Unresectable Hepatocellular Carcinoma：a Non-inferiority Study
This study tests if a one-day chemotherapy treatment is just as effective and safe as a two-day treatment for people with unresectable liver cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | lenvatinib, chemotherapy |
| Locations | 3 sites (Foshan, Guangdong and 2 other locations) |
| Trial ID | NCT05476432 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of two different regimens of hepatic arterial infusion chemotherapy (HAIC) using FOLFOX for patients with unresectable hepatocellular carcinoma (HCC). The study compares a one-day treatment regimen to a two-day regimen, aiming to determine if there is a non-inferiority in outcomes between the two approaches. Additionally, the trial explores the predictive power of thymidylate synthase (TYMS) in relation to treatment efficacy. Eligible patients include those with specific stages of HCC and certain laboratory parameters, ensuring a focused patient population for the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with unresectable hepatocellular carcinoma staged BCLC A, B, or C and meeting specific health criteria.
Not a fit: Patients with cirrhosis beyond Child-Pugh class A or those with other severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing chemotherapy regimens for patients with unresectable liver cancer, potentially improving treatment outcomes.
How similar studies have performed: Previous studies have shown promising results with HAIC in treating unresectable HCC, suggesting that this approach may be effective, although the specific comparison of one-day versus two-day regimens is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Foshan, Guangdong and 2 other locations
- The First People's Hospital of Foshan — Foshan, Guangdong, China (Recruiting)
- Cancer Center Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- Guangzhou Twelfth People 's Hospita — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.