Diffuse Large B-Cell Lymphoma, Relapsed and Refractory, Transarterial Chemoembolization
Conditions
Brief 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.
Interventions
None listed
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China