Histologically or cytologically confirmed nasopharyngeal carcinoma according to the International Union Against Cancer and American Joint Committee on Cancer staging line at the time of enrollment Nasopharyngeal carcinoma stage IVb as defined by the 8th edition.
Conditions
Interventions
A:Penpulimab (200 mg on the first day of each cycle, Q3W until no longer clinically beneficial) Cisplatin (80 mg/m^2, administered on the first day of each cycle, Q3W, 46 cycles) Gemcitabine (100 mg/m
B:Penpulimab (200 mg on day 1 of each cycle, Q3W until no longer clinically beneficial) Cisplatin (80 mg/m^2 on day 1 of each cycle, Q3W, 4-6 cycles) Gemcitabine (1000 mg/m^2, given on days 1 and 8 of
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written ICF voluntarily. 2. Age >= 18 years old, = 3 months. 5. Nasopharyngeal carcinoma diagnosed histologically or cytologically was stage IVb nasopharyngeal carcinoma as defined by the International Union against Cancer and the American Joint Committee on Cancer Staging System, Edition 8, at the time of enrollment. 6. The subjects had no distant metastasis at first diagnosis of nasopharyngeal carcinoma, had previously received platinum-containing chemotherapy (induction, synchronous or adjuvant chemotherapy), had developed distant metastasis more than 6 months after the end of treatment, and had not received systematic treatment for metastatic nasopharyngeal carcinoma. 7. Have at least one measurable lesion according to RECIST v1.1. 8. Agree to provide previously archived tumor tissue samples (tissue samples within 3 years prior to enrollment) or conduct biopsy to collect tumor lesion tissues (at least 3 unstained FFPE pathological sections). If the samples are determined by the central laboratory to be insufficient for PD-L1 IHC detection, An additional 3 unstained FFPE pathological sections are required to be sent to the central laboratory for PD-L1 immunohistochemical (IHC) testing (preferably recently acquired tumor tissue samples). A tumor lesion intended for biopsy should not be used as a target for disease assessment unless there are no other lesions suitable for biopsy. If the biopsy lesion is used as a target lesion, the biopsy must be performed outside the screening period. If there are no tumor tissue samples on file within 3 years, the investigator determines that biopsy may increase the risk of the subject, and after discussion with the medical monitor, it is agreed that archived tumor tissue samples beyond 3 years may be collected. 9. Good organ function is determined by the following requirements: a) Hematology (no use of blood components and cell growth factors to support therapy within 7 days prior to initiation of study therapy) : i. Neutrophil absolute value ANC >= 1.5 ×10^9/L (1,500/mm^3); ii. Platelet count >= 100 × 10^9/L (100,000/mm^3); iii. Hemoglobin >= 90 g/L. b) Kidney: i. Creatinine clearance * (CrCl) calculated value >= 50 mL/min* The Cockcroft-Gault formula will be used to calculate CrCl (Cockcroft-Gault formula)CrCL (mL/min) = {(140 - age) × body weight (kg) × F}/ (SCr (mg/dL) × 72) where F = 1 for males and F = 0.85 for females; SCr = serum creatinine. ii. Urinary protein =28 g/L d) Coagulation function: i. International Standardized ratio (INR) and activated partial thromboplastin time (APTT) =50%. 10. Female subjects with fertility must undergo urine or serum pregnancy test within 3 days before the first medication (if the urine pregnancy test result is not confirmed negative, serum pregnancy test is required, the serum pregnancy result shall prevail), and the result is negative. If a fertile female subject has sex with an unsterilized male partner, the subject must use an acceptable contraceptive method since screening and must consent to continued use of the contraceptive method for 120 days after the
Exclusion criteria
Exclusion criteria: 1. In addition to nasopharyngeal carcinoma, subjects had other malignant tumors within 2 years prior to enrollment. Subjects who have been cured by local treatment of other tumors, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. 2. Participated in the treatment of the investigational drug or used the investigational device within 4 weeks prior to the initial study administration. 3. Palliative local treatment was performed for non-target lesions within 2 weeks before the first administration; Received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to initial administration; Received Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 1 week prior to the first administration. 4. Subjects whose nasopharyngeal lesions recurred after radiotherapy and received secondary radiotherapy. 5. Previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as: ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the immune mechanism of tumor; Previously received antiangiogenic therapy (except bevacizumab and Endol). 6. Patients with active autoimmune disease that has required systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants) and replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered a systemic treatment. 7. Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption; Be active or have a clear past history of inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or chronic diarrhea. 8. History of immune deficiency; HIV antibody test positive; Systemic corticosteroid hormones or other immunosuppressants are currently being used on a long-term basis. 9. Subjects with known active tuberculosis (TB) and suspected active TB should be examined by chest X-ray, sputum, and excluded through clinical signs and symptoms; Known active syphilis infection. 10. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 11. There is a history or current presence of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy. 12. Severe infection occurring within 4 weeks prior to initial dosing, including but not limited to comorbidification requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within two weeks prior to initial dosing. 13. Subjects with untreated active hepatitis B (HBsAg positive with more than 1000 copies /m of HBV-DNA (l 200 IU/ml) or higher than the lower limit of detection, whichever is higher), for subjects with hepatitis B, are required to receive anti-hepatitis B therapy during the study treatment; Active hepatitis C subjects (HCV antibody positive with HCV-RNA levels above the lower limit of detection). 14. Had a major surgical procedure or severe trauma within 30 days prior to the first dose, or had a major surgi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactChen Xiaozhong
Zhejiang Cancer Hospital
Outcome results
None listed