Hepatic Artery Infusion of Adebrelimab Combined With Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma With Failure of Systemic Therapy Combined With Interventional Therapy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuiKai Li

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • HAIC
  • Adebrelimab
  • Bevacizumab

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

HuiKai Li

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Sponsor institution