RecruitingNCT07658833

TACE and/or HAIC Combined With Molecular-targeted Therapy and Immunotherapy for HCC

Study of the Safety, Clinical Efficacy and Prognostic Factors of TACE and/or HAIC Combined With Molecular-targeted Therapy and Immunotherapy for Hepatocellular Carcinoma


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

120 participants

Start Date

Jul 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The safety, clinical efficacy and prognostic factors of transcatheter arterial chemoembolization (TACE) and/or hepatic artery infusion chemotherapy (HAIC) combined with targeted immunotherapy for primary hepatocellular carcinoma (HCC) require further in-depth study. This research aims to evaluate the safety, clinical efficacy and prognostic factors of TACE and/or HAIC combined with targeted immunotherapy for hepatocellular carcinoma. We are going to compare and analyze local tumor response, survival outcomes, prognostic factors and adverse events. Tumor response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) version. Adverse events were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This study intends to include the targeted and immunotherapy applied, mainly including: lenvatinib, sorafenib, apatinib, bevacizumab, etc.; pembrolizumab, carfilzomib, sintilimab and teprotumumab, etc.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • aged 18-80 years
  • Eastern Cooperative Oncology Group (ECOG) performance status score < 2
  • maximum tumor diameter ≥ 7 cm
  • IVC/RA TT diagnosed by contrast-enhanced CT / MRI before study treatment
  • unresectable HCC (uHCC) confirmed by a specialized multidisciplinary team
  • liver function of Child-Pugh class A or B

Exclusion Criteria6

  • with other malignancies
  • prior anti-tumor therapy
  • history of drug allergy
  • autoimmune diseases
  • digestive hemorrhage of any grade
  • insufficient renal, bone marrow, or coagulation function

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Interventions

PROCEDURETACE (transarterial chemoembolization) combined with targeted/immunotherapy

transarterial chemoembolization


Locations(1)

Jiayan Ni

Guangzhou, None Selected, China

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NCT07658833


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