HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
Voluntarily participate in the study and sign the informed consent form;
Aged ≥18 years (calculated as of the date of signing the informed consent form);
Diagnosed with hepatocellular carcinoma (HCC) by clinical or pathological means;
Barcelona Clinic Liver Cancer (BCLC) stage C, with vascular/bile duct invasion or distant metastasis (excluding cases with Vp4-type tumor thrombus);
Disqualifiers
Patients with a severe allergy to iodine contrast agents who are unable to undergo hepatic arterial infusion chemotherapy (HAIC);
Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within one month prior to randomization;
Active infections that cannot be effectively controlled;
Severe gastroesophageal varices; untreated or incompletely treated gastroesophageal varices (with bleeding or high risk of bleeding);
Trial design
Treatments tested in this trial
- HAI Adebrelimab
- intravenous infusion (IV) of Adebrelimab (ADE)
- intravenous infusion (IV) of Bevacizumab (Bev.)
- HAIC with FOLFOX regimen
- Adebrelimab and bevacizumab maintainance treatment
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Henan Provincial People's Hospital
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
The Seventh Affiliated Hospital of Sun Yat-sen University
Collaborator
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Collaborator
West China Hospital
Collaborator
Hunan Provincial Cancer Hospital
Collaborator
Gansu Provincial Cancer Hospital
Collaborator
Source ClinicalTrials.gov