RecruitingPhase 3NCT05476432

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

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


Sponsor

Sun Yat-sen University

Enrollment

300 participants

Start Date

Jul 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two versions of a chemotherapy treatment delivered directly into the liver's blood supply (called HAIC, or hepatic artery infusion chemotherapy) for people with liver cancer that cannot be surgically removed. One version takes one day to deliver; the other takes two days. The goal is to see if the shorter version works just as well. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC) that cannot be removed by surgery - Your liver function is relatively preserved (Child-Pugh class A or no cirrhosis) - Your blood counts, liver enzymes, and kidney function meet the required levels - You have at least one tumor that can be measured **You may NOT be eligible if...** - You have had significant gastrointestinal bleeding in the past 30 days - You have serious heart problems - You have signs of liver failure (like fluid build-up, bleeding, or confusion) - You have HIV or a history of organ transplant - You have known allergies to the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHAIC

The microcatheter was advanced into the hepatic artery, and patients were transferred to the inpatient ward for drug infusion via the hepatic artery

DRUGFOLFOX 2d

Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 46 hours

DRUGFOLFOX 1d

Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 23 hours


Locations(3)

The First People's Hospital of Foshan

Foshan, Guangdong, China

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT05476432


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