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TACE Plus Ivonescimab for Unresectable Non-Metastatic HCC | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

NCT06990620•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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) subtypes, including: Fibrolamellar hepatocellular carcinoma Sarcomatoid hepatocellular carcinoma Mixed hepatocellular-cholangiocarcinoma
•Prior local therapy targeting the index lesion(s), including but not limited to: Transarterial chemoembolization (TACE) Transarterial embolization (TAE) Transarterial radioembolization (TARE) Hepatic arterial infusion chemotherapy (HAIC) Radiofrequency ablation (RFA) Cryoablation High-intensity focused ultrasound (HIFU) Radiation therapy
•Prior systemic anti-cancer therapy for hepatocellular carcinoma, including but not limited to: Molecular targeted agents (e.g., tyrosine kinase inhibitors, anti-angiogenic drugs) Conventional chemotherapy Immunotherapy: Immune checkpoint inhibitors (e.g., PD-1/PD-L1/CTLA-4 inhibitors) Immune checkpoint agonists Cellular immunotherapy (e.g., CAR-T, NK cell therapy) Biological therapy: Cancer vaccines Cytokines (e.g., interferons, interleukins) Growth factor inhibitors
•Macrovascular invasion meeting either of the following criteria: Portal vein tumor thrombus (PVTT): Vp3: Tumor thrombus involving the first-order branches (left or right portal vein) Vp4: Tumor thrombus involving the main portal trunk or extending beyond Hepatic vein/inferior vena cava (IVC) tumor thrombus
•History of bleeding events within 6 months prior to initial treatment, including but not limited to: Acute hemorrhage from esophageal or gastric varices caused by portal hypertension AND/OR 6. Untreated or inadequately treated esophageal/gastric varices with high bleeding risk, as assessed by the investigator
•Clinically significant cardiovascular or cerebrovascular disease, including any of the following within 3 months prior to initial treatment: Congestive heart failure (NYHA Class ≥II) Myocardial infarction Cerebrovascular accident (stroke/TIA) Unstable arrhythmia Unstable angina OR 8. History of congenital long QT syndrome OR 9. Screening ECG showing QTc interval \>500 ms (calculated by Fridericia's formula)
•Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years prior to initial treatment, with the following exceptions: Non-systemic replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal/pituitary insufficiency)
•Known HIV-positive status or history of active acquired immunodeficiency syndrome (AIDS)
•History of allogeneic stem cell transplantation or solid organ transplantation
•History of other active malignancies within 5 years prior to initial treatment, except for those with negligible risk of metastasis or death (e.g., 5-year overall survival rate \>90%), including: Adequately treated carcinoma in situ of the cervix Non-melanoma skin cancer Localized prostate cancer (Gleason score ≤6, treated if required) Superficial bladder cancer (Ta/Tis, non-invasive)
+5 more criteria

Key Dates

Start Date

June 1, 2025

Primary Completion Date

June 1, 2027

Completion Date

December 1, 2027

Last Updated

May 25, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

TACE+AK112

COMBINATION_PRODUCT

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

NCT07291076

Hepatocellular Carcinoma (HCC)

View study

RECRUITING

NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

NCT07365930

Hepatocellular Carcinoma (HCC)

View study

RECRUITINGPHASE4

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TACE Plus Ivonescimab for Unresectable Non-Metastatic HCC

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (Selective Internal Radiation Therapy) Therapy and Hepatic Arterial Infusion Chemotherapy (Hepatic Artery Infusion Chemotherapy) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma

Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

Multiparametric MRI for Characterization of Hepatocellular Carcinoma