Recurrent / metastatic nasopharyngeal carcinoma
Conditions
Interventions
Trial group:Irinotecan liposome, 70 mg/m^2, i.v., Day 1, every 3 weeks + Epalrestat, 5 mg/kg, i.v., Day 1, every 3 weeks
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years at enrollment; 2. ECOG performance status 0-1; 3. Histologically or cytologically confirmed, recurrent/metastatic non-keratinizing nasopharyngeal carcinoma (RM-NPC) with disease progression after at least one line of platinum-based chemotherapy combined with anti-PD-1(L)1 therapy; 4. Epstein-Barr virus-encoded small RNA (EBER) positive by in situ hybridization; 5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by imaging; 6. Expected survival >= 3 months; 7. Organ function must meet all of the following criteria: (1) Hematologic: 1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; 2) Hemoglobin (HB) >= 90 g/L; 3) Platelet count (PLT) >= 90 × 10^9/L; (2) Hepatic function: 1) AST, ALT, and ALP = 30 g/L; (3) Renal function: Calculated creatinine clearance (CrCl) >= 60 mL/min (using the Cockcroft-Gault formula) OR serum creatinine <= 1.5 × ULN; (4) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5 × ULN; 8. Female subjects of childbearing potential (theoretically aged 15–49 years, including unmarried, married, or widowed) must have a negative serum pregnancy test within 3 days prior to first dose; such female subjects must use an acceptable method of contraception from screening onward and agree to continue using contraception for at least 6 months after the last dose of study drug; non-sterilized male subjects must use an acceptable method of contraception from screening onward and for at least 6 months after the last dose of study drug; the exact duration for discontinuing contraception shall be determined by the investigator; 9. The subject voluntarily participates in this study, is able to comply with treatment, scheduled assessments, follow-up, and other study-related requirements, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The presence of other components other than nasopharyngeal carcinoma in tissue or cell pathology. 2. In addition to the diagnosis of nasopharyngeal carcinoma, the subject had a history of other types of malignant tumors within 5 years prior to the first dose of medication, including tumors that were cured by adequate treatment. 3. Patients received radiotherapy within 4 weeks before enrollment; 4. Subjects with active hepatitis B (HBsag-positive and HBV-DNA > 1000 copies /ml (200 IU/ml) or higher than the lower limit of detection) and treatment-stable hepatitis B could be enrolled in the study, and they were required to receive anti-HBV treatment during the study; Subjects with active hepatitis C (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection). 5. History of immunodeficiency, including HIV positive; 6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 7. Patients who did not recover to NCI-CTC AE= grade 1 after previous systemic antitumor therapy; 8. A history of drug, alcohol or drug abuse; 9. Pregnant or lactating women; 10. Active autoimmune disease, except vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; Hypothyroidism due to autoimmune thyroiditis requires only stable doses of hormone replacement therapy. Type I diabetes requiring only stable doses of insulin replacement therapy; 11. Received live vaccine (including live attenuated vaccine) within 28 days before study dose; 12. Illness requiring systemic corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive drugs (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks before the first dose. Topical corticosteroids, nasal sprays, and inhaled steroids were allowed. Systemic corticosteroids were allowed to prevent contrast allergy; 13. Patients who were allergic to irinotecan or irinotecan liposome and who did not stop using strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 2 weeks before enrollment; 14. Previous treatment with immune checkpoint inhibitors other than anti-PD -(L)1, including anti-CTLA-4 antibody, anti-LAG-3 antibody, anti-TIM-3 antibody, etc. 15. Previous immune-related adverse events leading to the discontinuation of anti-PD -(L)1 therapy; 16. Subjects have other underlying diseases, infections, treatments, and laboratory abnormalities that are not well controlled, which may confound the study results, affect the full participation of subjects in the study, or may not be in the best interests of subjects to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Progression-free survival;Duration of response;Safety (including incidence and severity of adverse events, clinically significant abnormal laboratory findings); | — |
Countries
China
Contacts
Public ContactSui Jiangdong
Chongqing University Cancer Hospital
Outcome results
None listed