Prospective Single Arm, Single Center, Phase II Clinical Study of Hepatic Artery Infusion of Adebrelimab Combined With Bevacizumab Treatment System for Advanced Hepatocellular Carcinoma With Failure of Systemic Therapy Combined With Interventional Therapy

HuiKai Li1 site in 1 country30 target enrollmentSeptember 15, 2023

ConditionsHepatocellular Carcinoma

InterventionsHAIC Adebrelimab Bevacizumab

DrugsAdebrelimab Bevacizumab

Overview

Phase: Phase 2
Intervention: HAIC
Conditions: Hepatocellular Carcinoma
Sponsor: HuiKai Li
Enrollment: 30
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 15, 2023

End Date

July 31, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

HuiKai Li

Responsible Party

Sponsor Investigator

Principal Investigator

HuiKai Li

Director

Tianjin Medical University Cancer Institute and Hospital

Eligibility Criteria

Inclusion Criteria

•Non resectable advanced hepatocellular carcinoma confirmed by pathological and clinical imaging examinations.
•Patients who have previously received systematic treatment combined with failed or intolerable interventional therapy.
•Male or female, aged ≥ 18 years at the time of signing the Informed consent form (ICF).
•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.
•The patient's Eastern Oncology Collaborative Group (ECOG) physical condition score is 0 or
•The patient's organ and blood system functions meet the requirements:
•Hematology function: Absolute neutrophil count (ANC) ≥ 1.5 x 10 \^ 9/L, platelet count ≥ 75 x 10 \^ 9/L
•Adequate renal function: serum creatinine\<1.5x ULN or creatinine clearance rate\>40 mL/min (Cockcroft Fault formula)
•Liver function: Total bilirubin ≤ 1.5 x ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 5 x ULN
•Coagulation function: Within the normal range of Prothrombin time (PT) .

Exclusion Criteria

•Has a history of allergies to any component of the study drug in the past;
•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;
•There are known Contraindication of percutaneous hepatic artery infusion;
•Has received or is currently receiving any of the following treatments in the past:
•The patient underwent major surgical procedures within 14 days prior to entering the study (puncture biopsy is not included)
•Previous or planned immune therapy such as Chimeric antigen receptor T cell immunotherapy (CAR-T) and vaccines
•Have any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, enteritis, hepatitis, hypophysitis, Vasculitis, nephritis, hyperthyroidism, hypothyroidism (it can be considered to be included after hormone replacement treatment); Patients with psoriasis or childhood asthma/allergy that has completely alleviated and does not need any intervention after adulthood can be considered for inclusion, but patients who need medical intervention with Bronchiectasis cannot be included;
•Poor nutritional status, BMI\<18.5 Kg/m2; If symptomatic nutritional support is provided and corrected before enrollment, and evaluated by the main investigator, enrollment can continue to be considered;
•Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;
•There are clinical symptoms or diseases of the heart that cannot be well controlled, including but not limited to: (1) New York Heart Association (NYHA)grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that have not undergone clinical intervention or are still poorly controlled after clinical intervention;

Arms & Interventions

HAIC+Adebrelimab+Bevacizumab

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.

Intervention: HAIC

HAIC+Adebrelimab+Bevacizumab

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.

Intervention: Adebrelimab

HAIC+Adebrelimab+Bevacizumab

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.

Intervention: Bevacizumab