RecruitingNCT06323382

Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma

Efficacy of Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma: a Multicenter, Observational, Real-world Study


Sponsor

Sun Yat-sen University

Enrollment

240 participants

Start Date

Jan 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a combined approach for treating advanced liver cancer (hepatocellular carcinoma, or HCC) using locoregional therapy — procedures that target tumors directly in the liver — together with bevacizumab (a drug that cuts off blood supply to tumors) and a checkpoint inhibitor (an immunotherapy drug). Researchers are studying whether this combination improves survival. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with HCC at an intermediate or advanced stage (BCLC stage B or C) - Your liver function is relatively preserved (Child-Pugh A or B) - Your physical fitness score (ECOG) is 0–2 - Your blood counts and organ function are within acceptable levels **You may NOT be eligible if:** - Your liver function is severely impaired (Child-Pugh C) - Your physical status is too poor (ECOG above 2) - Your blood counts or organ function are below acceptable thresholds 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

PROCEDURELocoregional therapy

TACE procedure The decision to utilize transarterial artery chemoembolization (TACE) was performed through the tumor-feeding artery. The embolization emulsion was a mixture of Epirubicin 30-60 mg, Lobaplatin 30-50 mg, and Lipiodol 10-30 ml, and it was infused into tumor-feeding arteries via a 2.7/2.8 Fr micro-catheter. HAIC procedure Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 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.

DRUGBevacizumab

15mg/kg or 7.5mg/kg intravenously every 3 weeks

DRUGAtezolizumab

1200mg intravenously every 3 weeks

DRUGTislelizumab

200mg intravenously every 3 weeks

DRUGToripalimab

220mg intravenously every 3 weeks

DRUGSintilimab

200mg intravenously every 3 weeks

DRUGCamrelizumab

200mg intravenously every 3 weeks


Locations(1)

Chinese PLA hospital

Beijing, Beijing Municipality, China

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NCT06323382


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