DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

NCT06190665 | Recruiting

• 1 other identifier: CHANCE 2305
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; TACE; Microspheres

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Visualization score of embolic area

  Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment

• Embolization success rate of target lesions

  Immediately after each TACE treatment

• Equipment performance evaluation

  From the begin to immediately after each TACE treatment

• Disease control rate (DCR) for target lesions

  1 month after the first TACE treatment, and 3 months after the last TACE treatment

• Objective response rate（ORR）

  1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment

Study Arms (2)

Visualable microspheres

EXPERIMENTAL

DEB-TACE with visualable microspheres

Device: DEB-TACE with visualable microspheres

PVA microspheres

ACTIVE COMPARATOR

DEB-TACE with polyvinyl alcohol microspheres

Device: DEB-TACE with PVA microspheres

Interventions

DEB-TACE with visualable microspheres DEVICE

Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres

Visualable microspheres

DEB-TACE with PVA microspheres DEVICE

Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres

PVA microspheres

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Zhongda Hospital，Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Gao-Jun Teng

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai-Dong Zhu

CONTACT

+86-25-83272121; zhuhaidong9509@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Model Details: DEB-TACE with visualable microspheres or PVA microspheres

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: December 19, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

CN (2)