RecruitingNot ApplicableNCT05788835
DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial
Drug-eluting Bead Transarterial Chemoembolization and Drug-eluting Bead Transarterial Chemoembolization Sequential Hepatic Artery Chemotherapy Infusion for Unresectable BCLC Stage C HCC: A Randomized Controlled Trial
Sponsor
Xuhua Duan
Enrollment
220 participants
Start Date
Mar 7, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria10
- 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.
- Expected life span ≥ 3 months.
- No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.
- Child-Pugh A-B.
- HBV DNA<2000 IU/ml.
- Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
- Patients sign informed consent, good compliance, cooperate with treatment.
Exclusion Criteria10
- 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.
- A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
- Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
- Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.
- Systemic failure, estimated survival time <3 months.
- Severe renal dysfunction.
- The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
PROCEDUREDEB-TACE and HAIC
Drug-eluting bead transarterial chemoembolization sequential Hepatic Artery Chemotherapy Infusion
PROCEDUREDEB-TACE
Drug-eluting bead transarterial chemoembolization
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05788835
Related Trials
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
NCT044727671 location
Optimizing Y90 Therapy for Radiation Lobectomy
NCT043907242 locations
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
NCT068233752 locations
SBRT in HCC With Oligoprogression on First-line Immunotherapy
NCT064344801 location
Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC
NCT0452254412 locations