Last updated: January 10, 2024
Sponsor: Zhongda Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Carcinoma
Abdominal Cancer
Liver Disorders
Treatment
DEB-TACE with PVA microspheres
DEB-TACE with visualable microspheres
Clinical Study ID
NCT06190665
CHANCE 2305
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and arenot suitable for or refuse surgical resection, liver transplantation, or ablationLiver function classification of Child-Pugh A or B
- ECOG PS score of 0-2
- With measurable lesions that had not been embolized (if there are more than 3 lesions,select the three largest lesions as target lesions, and the maximum diameter of targetlesion is ≤10cm)
- Agree to participate in this trial and voluntarily sign the informed consent form
Exclusion
Exclusion Criteria:
- Target lesions were embolized, or will require concomitant ablation or radiotherapyafter TACE treatment(s)
- With diffuse liver tumor or extrahepatic metastasis, expected survival <6 months Withsepsis or multiple organ dysfunction
- Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine >2 mg/dL)
- Significant reductions in white blood cells or platelets (white blood cells <3.0×10^9/L, platelets <50×10^9/L, hemoglobin<60g/L) that cannot be corrected (exceptsplenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectablecoagulation dysfunction (PT prolonged by >3 seconds above the upper limit of normal)
- With severe infection (>5 times the upper limit of normal white blood cells) The mainportal vein was completely embolized by tumor thrombus without collateral blood supply
- With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venousfistula) in the target lesion supplying arteries
- Angiography shows vascular anatomy obstruction or vasospasm that will affect thecatheter placemenr embolic agent injection
- Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials oranthracycline t ochemotherapy drugs
- Pregnant or lactating women
- Patients who are participating in other trial(s)
- Unsuitable for participation in this trial deemed by the researchers
Study Design
Total Participants: 188
Treatment Group(s): 2
Primary Treatment: DEB-TACE with PVA microspheres
Phase:
Study Start date:
December 19, 2023
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Peking University First Hospital
Beijing, Beijing 100034
ChinaActive - Recruiting
Zhongda Hospital,Southeast University
Nanjing, Jiangsu 210009
ChinaActive - Recruiting
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