RecruitingNot ApplicableNCT06070636

bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma

Sequential bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma


Sponsor

Sun Yat-sen University

Enrollment

30 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of treatments — including a liver procedure (bTAE-HAIC), plus two drugs (lenvatinib and sintilimab) — for people with a particularly advanced form of liver cancer called infiltrative hepatocellular carcinoma. These tumors are large and ill-defined, making them hard to treat with conventional methods. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with infiltrative hepatocellular carcinoma (liver cancer) - Your tumor is large (at least 10 cm) or total tumor burden is at least 15 cm - You have limited or no spread to other organs (up to 5 metastases allowed) - Your liver function is reasonably preserved (Child-Pugh A or B) - Your overall health status is fair (ECOG score 0–1) **You may NOT be eligible if...** - You have major blood vessel invasion beyond certain limits - You have previously received systemic therapy (e.g., sorafenib) - You have serious heart or liver disease beyond the cancer - You are pregnant or breastfeeding 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

PROCEDUREbTAE-HAIC

bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). The microcatheter was reserved at the proper/left/right hepatic artery according tumor location. After the patient returned to the ward, the following FOLFOX-based regime was intra-arterially administered through the microcatheter. 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.

DRUGLenvatinib

12 mg (or 8 mg) once daily (QD) oral dosing.

DRUGSintilimab

200mg intravenously every 32 weeks


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06070636


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