HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable H… (NCT06737913) | Clinical Trial Compass
RecruitingPhase 2
HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma
China76 participantsStarted 2025-01-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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);
✓. No prior systemic therapy for HCC; or progression or residual lesions following prior local therapy for HCC (including but not limited to surgery, ablation, radiotherapy, or transarterial chemoembolization \[TACE\]), with an interval of at least one month between the last local treatment and enrollment;
✓. ECOG Performance Status (PS) score of 0-1 and Child-Pugh grade A or grade B with a score of 7;
✓. No history of autoimmune disease;
✓. An expected survival time of ≥3 months;
Exclusion criteria
✕. 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);
✕. Presence of brain metastases or bone metastases requiring urgent surgical or radiotherapy intervention;
✕. Pregnant or suspected to be pregnant, or currently breastfeeding;
✕. Current use or recent use (within 10 days before the initiation of the study treatment) of aspirin (\>325 mg/day, maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
✕. Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, or cerebral infarction) or pulmonary embolism, occurring within six months prior to the initiation of the study treatment;