The goal of this prospective single arm, Phase II Clinical Study is to explore and evaluate the efficacy and safety of hepatic artery infusion of Adebrelimab combined with Bevacizumab in the treatment of patients with advanced hepatocellular carcinoma who failed in systematic therapy combined with interventional therapy.
Participants will receive hepatic artery infusion of Adebrelimab 1200mg, d1, q3w, combined with hepatic artery infusion of Bevacizumab 5mg/kg, d1, q3w, HAIC treatment for 3-4 times.
1. Non resectable advanced hepatocellular carcinoma confirmed by pathological and clinical imaging examinations.
2. Patients who have previously received systematic treatment combined with failed or intolerable interventional therapy.
3. Male or female, aged ≥ 18 years at the time of signing the Informed consent form (ICF).
4. The liver should have at least one measurable target lesion (RECIST v1.1). If it is an active lesion after local treatment (radiotherapy, ablation, transcatheter arterial chemoembolization, etc.), local treatment should be completed 4 weeks before the screening period imaging examination.
1. Has a history of allergies to any component of the study drug in the past;
2. Known to be allergic to Programmed Death-1/Programmed Death-L1 (PD-1/PD-L1) antibodies or have experienced drug-related Immune related adverse events (irAEs) in the past, in accordance with the "Guidelines Of Chinese Society Of Clinical Oncology [CSCO]Management Of Immune Checkpointinhibitor-Related Toxicity 2019", it meets the indication for permanent discontinuation of medication;
3. There are known Contraindication of percutaneous hepatic artery infusion;
The patient underwent major surgical procedures within 14 days prior to entering the study (puncture biopsy is not included)
Single group
HAIC
Procedure/Surgeryhepatic artery infusion for 3-4 times.
Adebrelimab
Drughepatic artery infusion of Adebrelimab 1200mg, d1, q3w，for 3-4 times.
Bevacizumab
Drughepatic artery infusion of Bevacizumab 5mg/kg, d1, q3w, for 3-4 times.
Objective response rate (ORR)
Objective response rate
Progression-free survival (PFS)
Progression-free survival：The time from the start of treatment to the progression of the disease or death from any cause
Overall Survival (OS)
Overall Survival：The survival time from enrollment to death from any cause.
Disease Control Rate (DCR)
Disease Control Rate: Ratio of complete response (CR)+partial response (PR)+stable disease (SD)
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HuiKai Li
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
