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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07658833
Enrollment
120
Registered
2026-06-22
Start date
2026-07-01
Completion date
2028-06-30
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma (HCC)

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.

Interventions

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival(OS)1-, 2-, 3-, and 5-yearOS 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

MeasureTime frameDescription
Progression-free survival (PFS)1-, 2-, and 3-yearPFS 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026