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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

with other malignancies

prior anti-tumor therapy

history of drug allergy

autoimmune diseases

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • TACE (transarterial chemoembolization) combined with targeted/immunotherapy

    Procedure/Surgery

    transarterial chemoembolization

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: TACE-HAIC-MTT-PD-1i1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Progression-free survival (PFS)

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.

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

Other outcomes

Sponsors and contacts

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