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Recruiting Observational

Drug-Eluting Bead-Based Transarterial Chemoembolization (DEB-TACE) as a Local Salvage Therapy for Large Lesions in Relapsed and Refractory Diffuse Large B-Cell Lymphoma

NCT07198230 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Observational
Started
2025-03-01
Last updated
2025-11-18

Condition(s) studied

Diffuse Large B-Cell LymphomaRelapsed and RefractoryTransarterial Chemoembolization

Study summary

Current exploration of local therapies for large Diffuse Large B-Cell Lymphoma (DLBCL) masses remains in its infancy. This study aims to retrospectively evaluate the safety, efficacy, and tolerability of Drug-Eluting Bead-Based Transarterial Chemoembolization (DEB-TACE) for treating recurrent and refractory DLBCL masses. It seeks to establish a novel local salvage treatment strategy for such patients while providing preliminary theoretical foundations and clinical data to support future large-scale, multicenter clinical trials.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * (1) Age 18 to 75 years; (2) Pathologically confirmed diffuse large B-cell lymphoma (DLBCL); (3) Recurrence or treatment resistance following multiple therapeutic regimens (e.g., chemotherapy, immunotherapy, targeted therapy), with at least one clearly defined bulky lesion (maximum diameter ≥5 cm or imaging evidence of bulky lesion); (4) Imaging studies (CT, MRI, or PET-CT) confirm rich blood supply to the lesion, making it suitable for transarterial interventional therapy; (5) History of favorable response to doxorubicin-based agents during prior systemic therapy; (6) ECOG performance status ≤ 2; (7) Blood counts, hepatic and renal function, and coagulation parameters meet the following criteria: * Platelet count ≥ 30 × 10\^9/L; * Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the ULN; * Serum creatinine ≤ 2.5 times the upper limit of normal (ULN); * Prothrombin time international normalized ratio (INR) ≤ 1.5. (8) The patient has previously undergone at least one DEB-TACE treatment at this institution. Exclusion Criteria: * (1) Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction, or other serious comorbidities rendering them unable to tolerate interventional therapy; (2) Patients with active or uncontrolled severe infections; (3) Patients with severe coagulation disorders or bleeding tendencies; (4) Pregnant or lactating women, or patients planning pregnancy during the study period; (5) Allergy or contraindications to drug-eluting microsphere materials or chemotherapy drugs; (6) Psychiatric disorders or cognitive impairment preventing treatment compliance and follow-up; (7) Other conditions deemed unsuitable for study participation by the investigator.

Primary outcome measure(s)

  • Objective Response Rate — 3 months
    The objective response rate (ORR) refers to the proportion of patients whose tumor volume reduction reaches a predetermined threshold and is maintained for the minimum required duration. It is calculated as the sum of complete response (CR) and partial response (PR) rates, i.e., ORR = CR + PR.
  • Local Response Rate — 3 months
    The local lesion response rate typically refers to the proportion of local lesions that show a reduction in volume or improvement in symptoms following treatment.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07198230 on ClinicalTrials.gov ↗ ← All trials in China