A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) C… (NCT07128251) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)
47 participantsStarted 2025-08-20
Plain-language summary
This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in the study and provide written informed consent.
✓. Age 18-75 years, inclusive (male or female).
✓. Histologically or cytologically confirmed HCC, or clinically diagnosed HCC according to the \*Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition)\*.
✓. Barcelona Clinic Liver Cancer (BCLC) Stage A, B, or C, not amenable to curative treatment (e.g., surgical resection, liver transplantation, or ablation).
✓. At least one measurable lesion according to RECIST v1.1 criteria.
✓. Suitable candidate for Transarterial Chemoembolization (TACE) with no known allergy or contraindication to iodized oil or epirubicin.
✓. Child-Pugh Liver Function Class A.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Exclusion criteria
✕. Known fibrolamellar HCC, sarcomatoid HCC, mixed hepatocellular cholangiocarcinoma, or cholangiocarcinoma; history of other active malignancies within 5 years or concurrently with HCC. Cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma \*in situ\* of the prostate, cervix, or breast) are permitted.
✕. Presence of Vp3 or Vp4 portal vein tumor thrombosis (PVTT), any grade of hepatic vein or inferior vena cava invasion; any grade of bile duct invasion. \*Note: Vp1 or Vp2 PVTT is permitted.\*
What they're measuring
1
Progression-Free Survival (PFS) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
✕. Intrahepatic lesion(s) with maximum diameter ≥ 10 cm, \> 10 intrahepatic lesions, or intrahepatic tumor burden ≥ 70% of liver volume, per RECIST v1.1.
✕. Prior systemic anti-cancer therapy for HCC, including molecular targeted agents, cytotoxic chemotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune checkpoint agonists, cellular therapies), or biologic therapy (e.g., cancer vaccines, cytokines, growth factors).
✕. Prior locoregional therapy for HCC, including therapeutic TACE, transarterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE).