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
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
Treatments tested in this trial
- DEB-TACE and HAIC
- DEB-TACE
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xuhua Duan
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution
Source ClinicalTrials.gov