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Recruiting NCT07198230

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

Observational Diffuse Large B-Cell Lymphoma Relapsed and Refractory Transarterial Chemoembolization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diffuse Large B-Cell Lymphoma, Relapsed and Refractory, Transarterial Chemoembolization. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Objective Response Rate [Time frame: 3 months]
  • Local Response Rate [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou

Identifiers

NCT: NCT07198230 · DLBCL-DEBTACE-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗