Clinical trial NCT06190665: DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
Official title: DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
TACE
Microspheres
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: DEB-TACE with visualable microspheres or PVA microspheres
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.

Detailed description: This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.

Eligibility criteria: Inclusion Criteria:

* CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver 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 target lesion is ≤10cm)
* Agree to participate in this trial and voluntarily sign the informed consent form

Exclusion Criteria:

* Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
* With diffuse liver tumor or extrahepatic metastasis, expected survival \<6 months With sepsis 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 (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation 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 main portal vein was completely embolized by tumor thrombus without collateral blood supply
* With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
* Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
* Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline 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

Primary outcomes:
measure: Disease control rate (DCR) for target lesions 1 month after the last TACE treatment
timeFrame: 1 month after last TACE treatment
Secondary outcomes:
measure: Visualization score of embolic area
timeFrame: Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment
measure: Embolization success rate of target lesions
timeFrame: Immediately after each TACE treatment
measure: Equipment performance evaluation
timeFrame: From the begin to immediately after each TACE treatment
measure: Disease control rate (DCR) for target lesions
timeFrame: 1 month after the first TACE treatment, and 3 months after the last TACE treatment
measure: Objective response rate（ORR）
timeFrame: 1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment
measure: Number of TACE treatments for target lesions
timeFrame: 6 month since the last TACE treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Nanjing
country: China
facility: Zhongda Hospital，Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng
role: PRINCIPAL_INVESTIGATOR
References: