NCT07084662 Xinlikang Capsule for Chemotherapy-induced Fatigue and Immune Disorders in Diffuse Large B Lymphoma

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 80 participants in total. It began in 2025-09-11 with a primary completion date of 2028-08-01.

Brief Summary

To evaluate the efficacy and safety of Xinlikang capsule in the treatment of cancer-related fatigue (CRF) and peripheral blood lymphocytes in patients with diffuse large B-cell lymphoma (DLBCL) who achieved complete remission (CR) after all courses of chemotherapy-containing regimens

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years old; 2. Newly diagnosed diffuse large B lymphoma (DLBCL); 3. Patients had completed the first-line treatment of chemotherapy and immunotherapy and the course of treatment had been completed. 4. Metabolic complete response (CR) was evaluated by PET/CT during or after chemotherapy. 5. Had completed the full course of chemotherapy-containing regimen for more than 30-90 days; 6. BFI fatigue score ≥4; 7. The expected survival time was ≥6 months; 8. No treatment plan for CD20 monoclonal antibody, radiotherapy, chemotherapy, lenalidomide, thymopeptides, targeted drugs, biological agents, immunosuppressive agents, other Chinese medicine decoction or Chinese patent medicine in the next 3 months; 9. No grade 3-4 surgery plan is expected in the next 3 months; 10. They had normal mental consciousness, could understand the content of the questionnaire correctly, and could complete the questionnaire with assistance or independently; 11. Women and men of childbearing age agreed to use contraception during and for 1 month after treatment; 12. They volunteered to participate in the clinical trial and signed the informed consent form, which was in accordance with the requirements of Good Clinical Practice (GCP). Exclusion Criteria: 1. DLBCL subjects with CNS involvement at initial diagnosis; 2. Allergic or intolerant to Xinlikang capsule or its component drugs; 3. Significant abnormal liver and kidney function: ALT, AST, GGT≥3 ULN; BUN and Cr≥3 ULN; 4. Severe abnormal bone marrow function: white blood cell ≤1.0×10\^9/L, neutrophil ≤0.5×10\^9/L, platelet ≤30×10\^9/L, hemoglobin ≤6g/dL; 5. Patients with HIV virus infection, bacterial infection and other immune-related diseases that affect immune function as judged by clinicians; 6. Uncontrolled HBV or HCV infection: Hepatitis B Virus (HBV) DNA testing exceeding the lower limit of detection or 1000 copies /mL or 500 IU/mL (the higher is the reference) during screening in patients with a history of chronic hepatitis B; HCV RNA detection in patients with a history of Hepatitis C Virus (HCV) infection during the screening period exceeded the detection limit of the assay or 1000 copies /mL or 500 IU/mL (whichever was higher was used as a reference). 7. Patients with other malignancies. 8. Enrollment in another clinical trial 30 days before screening or during the trial; 9. Persons who were deemed by the investigator to be ineligible to participate in the trial.

Contact & Investigator

Frequently Asked Questions

Related Trials