Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy

Inclusion Criteria

• •1. Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study;
• •2. Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender;
• •3. Patients must be diagnosed with malignant solid tumors by pathological histology or cytology in the central laboratory or study center;
• •4. Patients must received treatment with a chemotherapy regimen containing taxanes;
• •5. Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale
• •6. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2;
• •7. Expected survival of ≥ 3 months;
• •8. Screening values at screening meet the following requirements: (no blood components, cell growth factors, leukocyte-lifting drugs, platelet-lifting drugs, anemia-correcting drugs, etc. are allowed within 14 days prior to obtaining laboratory tests); Complete blood count: neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 90 × 109/L, hemoglobin (Hb) ≥ 90 g/L; Liver function: glutamic aminotransferase (AST), alanine aminotransferase (ALT) and total serum bilirubin (TBIL) ≤ 2 times the upper limit of normal range (ULN) Renal function: serum creatinine (Cr) ≤ ULN or creatinine clearance (CCr) ≥ 80 mL/min (applying the standard Cockcroft -Gault formula);
• •9. Female patients who are non-lactating and must have a negative pregnancy test result;
• •10. Patients of childbearing potential must agree to use effective contraception for at least 30 days after signing the informed consent to the last dose.
• •Note: Concomitant use of selected analgesics (e.g., opioids, acetaminophen, aspirin, and other NSAIDs) is permitted, but only patients receiving a stable dose during the two weeks prior to enrollment may participate.