RecruitingNot ApplicableNCT06609863

dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma

dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study

Sponsor

Sun Yat-sen University

Enrollment

27 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Advanced Hepatocellular Carcinoma Atezolizumab Bevacizumab

Summary

This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of treatments for large liver tumors (10 cm or more) caused by hepatocellular carcinoma (liver cancer). The combination includes TACE (blocking blood flow to the tumor), HAIC (directly infusing chemotherapy into the liver artery), plus two immunotherapy and targeted therapy drugs — bevacizumab and atezolizumab — to see if this aggressive combination approach can improve outcomes for this hard-to-treat group. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver cancer and your tumor is 10 cm or larger - You have intermediate to advanced stage disease, with limited spread (5 or fewer sites) - Your liver is still functioning adequately (Child-Pugh A or B) - You are in good to fair general health (ECOG 0–1) **You may NOT be eligible if...** - Your liver cancer is diffusely spread throughout the liver - You have more than 5 sites of spread outside the liver - You have serious blood clotting, liver, or kidney 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREdTACE-HAIC

dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres were used (100-300um). 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. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks