HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma
Sponsor: Sun Yat-sen University • ClinicalTrials.gov ID: NCT06737913
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
The purpose of this study is to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma. Patients will be randomized 1:1 etither to receive hepatic arterial infusion(HAI) Adabrelimab group or IV Adabrelimab group, and both groups will receive HAI FOLFOX chemotherapy and IV Bevacizumab.
Interventions
-
HAI Adebrelimab
(Procedure)
Hepatic arterial infusion (HAI) of Adebrelimab (ADE) (1200mg, IA, Q3W)
-
intravenous infusion (IV) of Adebrelimab (ADE)
(Drug)
intravenous infusion (IV) of Adebrelimab (ADE) (1200mg, IV, Q3W)
-
intravenous infusion (IV) of Bevacizumab (Bev.)
(Drug)
intravenous infusion (IV) of Bevacizumab (Bev.) (15mg/kg, IV, Q3W)
-
HAIC with FOLFOX regimen
(Procedure)
HAIC with FOLFOX regimen (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil bolus 400 mg/m2 on day 1, and 5-fluorouracil infusion 2500 mg/m2 for 46 hours via hepatic artery Q4W)
-
Adebrelimab and bevacizumab maintainance treatment
(Drug)
The two arms continue the triple combination treatment up to 6 cycles and then received receive intravenous combination therapy of adebrelimab and bevacizumab for maintainance until disease progression or intolerable toxicity
Eligibility criteria
Conditions
Locations
- Gansu Province Cancer Hospital — Lanzhou, Gansu, China
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
- Henan Cancer Hospital — Zhengzhou, Henan, China
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record