RecruitingNCT06641713

HAIC Compared With TACE in Huge Hepatocellular Carcinoma

Hepatic Arterial Infusion Chemotherapy Compared With Transcatheter Arterial Chemoembolizationin Intermediate-advanced Huge Hepatocellular Carcinoma: a Multicenter Retrospective Study


Sponsor

Sun Yat-sen University

Enrollment

664 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two liver-directed treatments — HAIC (chemotherapy delivered directly into the liver artery) vs. TACE (a combination of chemotherapy and artery blockage) — for people with very large liver tumors (hepatocellular carcinoma). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with primary liver cancer (hepatocellular carcinoma) - Your largest tumor is at least 10 cm - Your liver function is reasonably preserved (Child-Pugh A or B) - You have a good performance level (ECOG 0-1) - You have no more than 5 sites of cancer spread **You may NOT be eligible if...** - Your liver cancer has recurred after prior treatment - You have cancer spread to more than 5 sites outside the liver - The cancer is blocking a major blood vessel (portal vein type IV) - Your liver is failing (ascites, internal bleeding, or confusion from liver disease) - You have serious heart rhythm problems 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

PROCEDURETACE

TACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the TACE procedure was reached when there was no flow in the tumor-feeding vessels.

PROCEDUREHAIC

HAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks


Locations(1)

Chinese PLA general hospital

Beijing, Beijing Municipality, China

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NCT06641713


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