TACE Plus Ivonescimab for Unresectable Non-Metastatic HCC
A Prospective, Multicenter, Single-Arm Study on the Efficacy and Safety of Transarterial Chemoembolization Combined With Ivonescimab in Unresectable, Non-Metastatic Hepatocellular Carcinoma
Sponsor: Fudan University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR)
Time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 54 weeks relative to the date of randomization and then every 12 weeks thereafter. Assessed up to maximum of approximately 36 months.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years, male or female * Patients with histologically or pathologically confirmed hepatocellular carcinoma (HCC), or Patients meeting the clinical diagnostic criteria for hepatocellular carcinoma as defined by the American Association for the Study of Liver Diseases (AASLD) * BCLC Intermediate (B) or Advanced (C) stage, with liver-confined disease and ineligible for curative options (e.g., resection, transplant, or ablation) * Child-Pugh Class A (score 5-6) or Class B (score 7) * ECOG PS ≤1 * Measurable disease per RECIST 1.1 criteria * Life expectancy \>12 weeks * Adequate organ function meeting the following laboratory values: Hematological: Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelet count (PLT) ≥75×10⁹/L Hemoglobin (HGB) ≥90 g/L Hepatic: Total bilirubin (TBIL) ≤3× upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN Serum albumin ≥28 g/L Note: Patients may be enrolled if values stabilize after s…
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