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Recruiting
NCT06737913
HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma
Conditions: Advanced Hepatocellular Carcinoma (HCC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 76
Sponsor: Sun Yat-sen University
Location: Gansu Province Cancer Hospital Lanzhou Gansu
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.
Eligibility Criteria
Inclusion Criteria:
1. Voluntarily participate in the study and sign the informed consent form;
2. Aged ≥18 years (calculated as of the date of signing the informed consent form);
3. Diagnosed with hepatocellular carcinoma (HCC) by clinical or pathological means;
4. Barcelona Clinic Liver Cancer (BCLC) stage C, with vascular/bile duct invasion or distant metastasis (excluding cases with Vp4-type tumor thrombus);
5. 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;
6. ECOG Performance Status (PS) score of 0-1 and Child-Pugh grade A or grade B with a score of 7;
7. No history of autoimmune disease;
8. An expected survival time of ≥3 months;
9. At least one measurable lesion (per RECIST v1.1 criteria, the longest diameter of the measurable lesion on spiral CT scan must be ≥10 mm or the short axis of enlarged lymph nodes must be ≥15 mm; lesions previously treated locally can be considered target lesions if progression is confirmed per RECIST v1.1 criteria);
10. Sufficient hematologic, hepatic, and renal function, with laboratory tests within the following parameters performed within one week prior to enrollment:
* Neutrophil count ≥1.5×10\^9/L;
* Platelet count ≥75×10\^9/L;
* Hemoglobin ≥90 g/L;
* Serum ALT and AST ≤5×upper limit of normal (ULN); ⑤ Serum creatinine ≤1.5×ULN; ⑥ International Normalized Ratio (INR) \325 mg/day, maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
8. 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;
9. Congenital or acquired immunodeficiency;
10. History of other malignant tumors;
11. Any of the following conditions within 12 months prior to the initiation of the study: myocardial infarction, severe/unstable angina, or congestive heart failure;
12. Renal insufficiency requiring dialysis;
13. History of organ transplantation;
14. Severe acute or chronic physical or mental illnesses or laboratory abnormalities that may increase study risks or interfere with result interpretation, rendering the patient unsuitable for enrollment.
Source: ClinicalTrials.gov (NCT06737913). StuddyBuddy aggregates publicly available trial information.