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

Ting YANG

Status: Enrolling

Conditions: Transarterial Chemoembolization; Diffuse Large B-Cell Lymphoma; Relapsed and Refractory

Study type: Observational

Funder types: Other

Identifiers

NCT07198230

DLBCL-DEBTACE-01

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

DEB-TACE

Description:

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