DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190665
• Other study ID #: CHANCE 2305
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Zhongda Hospital
• Contact: Hai-Dong Zhu
• Phone: +86-25-83272121
• Email: zhuhaidong9509[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• DEB-TACE with visualable microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
• DEB-TACE with PVA microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	Zhongda Hospital,Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate (DCR) for target lesions 1 month after the last TACE treatment	Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.	1 month after last TACE treatment
Secondary	Visualization score of embolic area	Evaluation will be performed, based on CBCT images after the first TACE treatment, or CT plain images after the last TACE treatment as follow: 3 points: dense imaging (imaging area >75% of tumor area); 2 points: mixed imaging (imaging area 25%-75% of tumor area); 1 point: weak imaging (imaging area <25% of tumor area); 0 point: not visible (no imaging in the tumor area).	Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment
Secondary	Embolization success rate of target lesions	Defined as the number of successful embolizations for the target lesions / the total number of participants ×100%.	Immediately after each TACE treatment
Secondary	Equipment performance evaluation	Includes,the visualization performance of the microspheres on the fluoroscopy or cone-beam CT imaging; whether the microspheres can be easy pushed and pass through the catheter smoothly; whether the micro-catheter will be blocked during the process of pushing and releasing?	From the begin to immediately after each TACE treatment
Secondary	Disease control rate (DCR) for target lesions	Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images.	1 month after the first TACE treatment, and 3 months after the last TACE treatment
Secondary	Objective response rate(ORR)	Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images.	1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment
Secondary	Number of TACE treatments for target lesions	Totel times of TACE treatments for all target lesions	6 month since the last TACE treatment