TACE Plus Ivonescimab for Unresectable Non-Metastatic HCC (NCT06990620) | Clinical Trial Compass
Not Yet RecruitingPhase 1
TACE Plus Ivonescimab for Unresectable Non-Metastatic HCC
56 participantsStarted 2025-06
Plain-language summary
This study is a single-arm, multicenter, prospective clinical trial designed to evaluate the efficacy and safety of Transarterial Chemoembolization (TACE) combined with envafolimab in patients with unresectable, non-metastatic hepatocellular carcinoma (HCC), while exploring potential biomarkers associated with treatment response.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 standard liver support therapy for ≥1 week, as assessed by the investigator. Renal: Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula) Coagulation: International normalized ratio (INR) ≤2×ULN or Activated partial thromboplastin time (APTT) ≤2×ULN
* Willing and able to provide written informed consent prior to any study-related procedures
Exclusion Criteria:
* Patients with histopathologically confirmed variant hepatocellular carcinoma (HCC)…
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 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.