Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07658833

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiayan Ni

Guangzhou, None Selected, 510120, China

Location status: Recruiting

Location contact

Jiayan Ni, MD.

CONTACT

[email protected]

02034070680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

TACE (transarterial chemoembolization) combined with targeted/immunotherapy

Procedure

transarterial chemoembolization

Primary outcomes

  1. Overall survival(OS)

    Time frame: 1-, 2-, 3-, and 5-year

    OS was calculated as the duration from the date of the first cycle of the study combination therapy to the date of death or last date of follow-up.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 1-, 2-, and 3-year

    PFS was defined as the duration from the date of the first cycle of the combination therapy to tumor lesion progression, death, or last follow-up, whichever came first.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.