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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorTing YANG

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

(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.

Trial population

Relapsed and refractory diffuse large B-cell lymphoma with bulky lesions

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

10 Participants
are grouped into 1 trial group
Group A: DEB-TACE

Trial outcomes

Primary outcomes

1

Objective Response Rate

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.

Time frame
3 months
2

Local Response Rate

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.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Ting YANG

Lead sponsor

Fujian Medical University

Sponsor institution