HAI or IV of Adebrelimab, Combined with Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with advanced hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be surgically removed. The study aims to see how well a combination of medications, including Adabrelimab, Bevacizumab, and a chemotherapy regimen called FOLFOX, works when given through either the liver’s blood supply or through an intravenous (IV) line. Participants will be randomly assigned to one of the two treatment groups and will receive these medications as their first treatment for advanced HCC.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced HCC. They should not have received any prior systemic treatment for their cancer and must have a certain level of health, as indicated by specific lab tests. Participants can expect to receive close monitoring and support throughout the study. It is important to note that individuals with certain health conditions, such as severe allergies, active infections, or recent heart problems, will not be able to participate. This trial is currently recruiting participants and aims to gather more information on the safety and effectiveness of this treatment combination for advanced liver cancer.

Gender

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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; ③ Hemoglobin ≥90 g/L;
• • Serum ALT and AST ≤5×upper limit of normal (ULN);
• • Serum creatinine ≤1.5×ULN;
• • International Normalized Ratio (INR) \<2.3, or prothrombin time ≤ULN+6 seconds;
• • Albumin ≥30 g/L; ⑧ Total bilirubin ≤3×ULN. 11.Women of childbearing potential must have a negative serum or urine pregnancy test within seven days prior to study enrollment, must not be breastfeeding, and must agree to use contraceptive measures during the study and for six months after its conclusion; men must agree to use contraceptive measures during the study and for six months after its conclusion.
• Exclusion Criteria:
• • 1. Patients with a severe allergy to iodine contrast agents who are unable to undergo hepatic arterial infusion chemotherapy (HAIC);
• • 2. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within one month prior to randomization;
• • 3. Active infections that cannot be effectively controlled;
• • 4. Severe gastroesophageal varices; untreated or incompletely treated gastroesophageal varices (with bleeding or high risk of bleeding);
• • 5. Presence of brain metastases or bone metastases requiring urgent surgical or radiotherapy intervention;
• • 6. Pregnant or suspected to be pregnant, or currently breastfeeding;
• • 7. 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;
• • 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.