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.
The combination of anti-PD-L1 antibody and bevacizumab has been approved as the first-line treatment for advanced hepatocellular carcinoma (HCC). However, the overall response rate is still unsatisfactory and the prognosis of patients remains poor. Our previous retrospective analysis showed triple combination of hepatic arterial infusion chemotherapy (HAIC) of FOLFOX regimen plus adebrelimab (anti-PD-L1 antibody) and bevacizumab had a high response rate for advanced stage HCC patients. More, as the PD-L1 on intrahepatic tumors is the main target of anti-PD-L1 therapy, hepatic arterial infusion of anti-PD-L1 antibody may contribute to a synergistic effect. Herein, we aimed 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Hepatic arterial infusion (HAI) of Adebrelimab (ADE) (1200mg, IA, Q3W)
intravenous infusion (IV) of Adebrelimab (ADE) (1200mg, IV, Q3W)
intravenous infusion (IV) of Bevacizumab (Bev.) (15mg/kg, IV, Q3W)
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)
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
Gansu Province Cancer Hospital
Lanzhou, Gansu, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGObjective response rate (ORR)
Defined as the proportion of enrolled patients in each group who achieve either a complete response (CR) or partial response (PR) as the best response during the study, based on RECIST v1.1 criteria. Radiology imaging evaluations will be conducted every 6 weeks (or after every two treatment cycles) to assess treatment efficacy.
Time frame: 6 weeks
Progression-free survival (PFS)
The time from the start of treatment to the first occurrence of disease progression based on RECIST 1.1 criteria or death.
Time frame: 36 months
Overall survival(OS)
Overall Survival (OS): Patient survival status will be regularly monitored through on-site visits or telephone follow-ups after the end of study treatment until death. If a participant dies during the study, the actual time of death will be recorded.
Time frame: 36 months
Time to progression
Time from the date of initial treatment to disease progression based on RECIST 1.1 criteria.
Time frame: 36 months
Disease control rate
The proportion of patients with best response of complete remission, partial remission or stable disease based on RECIST 1.1 criteria.
Time frame: 36 months
Duration of response
Refer to the time from the first documentation of complete remission or partial remission to the time of imaging-based disease progression based on RECIST 1.1 criteria.
Time frame: 36 months
Best overall response
Refer to the best overall response between the date of enrollment to the date of disease progression or the initiation date of other sequential treatments.
Time frame: 36 months
Incidence and Severity of Adverse Events (AEs)
Evaluate the incidence and severity of adverse events (AEs) according to NCI-CTCAE v5.0 criteria.
Time frame: From the date of informed consent signature up to 30 days after the last dose of study treatment
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