Health TrialsbyHealthPanel

DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial

ConditionHCC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXuhua Duan

About this trial

This is a randomized controlled trial to determine the efficacy and safety of DEB-TACE versus DEB-TACE sequential HAIC for unresectable BCLC stage C HCC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).

The sum of the diameter of single or 2-3 tumors ≥5cm. Tumor stage: Stage C of BCLC.

Patient age between 18 and 75，male or female.

ECOG 0-1.

Disqualifiers

Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.

Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.

Diffuse liver cancer patients.

Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DEB-TACE and HAIC

    Procedure/Surgery

    Drug-eluting bead transarterial chemoembolization sequential Hepatic Artery Chemotherapy Infusion

  • DEB-TACE

    Procedure/Surgery

    Drug-eluting bead transarterial chemoembolization

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: DEB-TACE-HAICExperimental treatment 1 intervention
Group B: DEB-TACEActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time from the first DEB-TACE treatment to either radiological progression or death

Time frame
Time from the first DEB-TACE treatment to either radiological progression or death or up to 36 months

Secondary outcomes

1

Overall survival (OS)

Time from the first DEB-TACE treatment to death from any cause or the end of the study

Time frame
Time from the first DEB-TACE treatment to death or up to 36 months
2

Objective response rate (ORR)

Proportion of patients with reduction in stable in tumor burden of a predefined amount

Time frame
1, 3, 6,12 months after the first DEB-TACE treatment, up to death or 36 months, whichever came first
3

Disease control rate (DCR)

Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount

Time frame
1, 3, 6,12 months after the first DEB-TACE treatment, up to death or 36 months, whichever came first
4

Time to Progression (TTP)

Time to progression was defined as the period of time from the first on-study DEB-TACE to radiographic disease progression at any site by mRECIST

Time frame
Time from the first DEB-BACE treatment to either radiological progression up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuhua Duan

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Sponsor institution

Source ClinicalTrials.gov
Apply now