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

NCT07658833 | Recruiting

• 1 other identifier: SYSKY-2025-1049-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  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.

  1-, 2-, 3-, and 5-year

Secondary Outcomes (1)

• Progression-free survival (PFS)

  1-, 2-, and 3-year

Study Arms (1)

TACE-HAIC-MTT-PD-1i

Procedure: TACE (transarterial chemoembolization) combined with targeted/immunotherapy

Interventions

TACE (transarterial chemoembolization) combined with targeted/immunotherapy PROCEDURE

transarterial chemoembolization

TACE-HAIC-MTT-PD-1i

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

120 HCC patients who underwent TACE and/or HAIC combined with molecular-targeted therapy and immunotherapy between January 2021 and December 2025 were enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Jiayan Ni

Guangzhou, None Selected, 510120, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)