RecruitingNot ApplicableNCT06519578

Prospective Real-World Study of HAIC With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma

Prospective Real-World Study of Hepatic Arterial Infusion Chemotherapy (HAIC) With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma


Sponsor

RenJi Hospital

Enrollment

1,115 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective cohort study aimed at comparing the efficacy and safety of RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive FOLFOX-HAIC or RALOX-HAIC treatment.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This real-world study is tracking outcomes in people with liver cancer (hepatocellular carcinoma) who are receiving a type of chemotherapy delivered directly to the liver through the blood vessels (called HAIC, using either raltitrexed or 5-fluorouracil), to understand how well it works in everyday clinical practice. **You may be eligible if...** - You have been diagnosed with liver cancer (hepatocellular carcinoma) - You are receiving HAIC treatment as part of your standard care - You are willing to have your data and outcomes tracked **You may NOT be eligible if...** - You have significant fluid buildup in the chest, abdomen, or around the heart requiring repeated drainage - You have HIV, have had an organ transplant, or have had a bone marrow transplant - You have serious heart or blood vessel disease - You had a gastrointestinal bleed in the past 6 months - You have a severe active infection - You have another active cancer - You are pregnant 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

DRUGhepatic artery infusion chemotherapy

HAIC is a regional therapy that takes advantage of the fact that hepatic tumors, particularly hepatocellular carcinoma, predominantly receive their blood supply from the hepatic artery. The procedure typically involves the insertion of a catheter into the hepatic artery, often through a percutaneous approach or during a surgical procedure. FOLFOX (5-fluorouracil, leucovorin combined with oxaliplatin) or RALOX (raltitrexed combined with oxaliplatin) Q3W.


Locations(2)

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

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NCT06519578


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