Nasopharyngeal Carcinoma
Conditions
Interventions
Test group:cadonilimab in combination with TPC chemotherapy
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed diagnosis of non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated, i.e. WHO staging type II or III); 2. Confirmed diagnosis of metastatic or recurrent nasopharyngeal carcinoma that is not amenable to radical local treatment; 3. Patients who have failed prior immunotherapy (single agent or combination, first line or later line); 4. Age 18-70 years; 5. ECOG score of 0-1 and an expected survival of >= 3 months; 6. At least one measurable lesion (according to RECIST 1.1), lesions that have received radiotherapy that have clearly progressed on imaging and are measurable may be considered target lesions; 7:Adequate organ and bone marrow function: hemoglobin (HGB)= 85 g/L, white blood cells (WBC)= 3×10E9 /L, platelets (PLT)= 75×10E9 /L. Liver function: Total bilirubin (TBIL)<1.5 times upper limit of normal (ULN), alanine aminotransferase (ALT) and or aspartate aminotransferase (AST) <2.5 times the upper limit of normal (ULN); If the patient has liver metastases, ALT or AST<5 x ULN. Renal function: creatinine level =1.5ULN; 8: Voluntarily participate in this study and sign informed consent, accept and comply with the research protocol, laboratory examination, follow-up, etc; 9. Female subjects of childbearing potential and male subjects with fertile sexual partners must agree to use reliable contraception (e.g. condoms, contraceptive pills used regularly as prescribed, etc.) from screening until 6 months after the last treatment
Exclusion criteria
Exclusion criteria: 1. Pathology of keratinizing squamous cell carcinoma (WHO staging type I); 2. A history of monoclonal antibody hypersensitivity; 3. A known history of interstitial pneumonia; 4. A history of serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia; 5. Patients treated with aspirin (> 325 mg/day) or dipyridamole, ticlopidine, clopidogrel, and cilostazol within 3 weeks prior to dosing, anticoagulants requiring INR monitoring (e.g., warfarin), or any blood component and cell growth factor support therapy within 1 week prior to dosing; 6. Active infections requiring systemic therapy; 7. Patients with active hepatitis B (HBV-DNA >= 1000 IU/mL) despite treatment, except for patients with cured hepatitis C; 8. Receive TPC chemotherapy within 6 months before include in this trial; 9. Received the last radiotherapy or antineoplastic treatment within 3 weeks prior to the first dose; 10. Patients with a known history of active tuberculosis, or patients with autoimmune diseases; 11. Patients with HIV infection; 12. Concurrently suffering from other uncontrolled malignancies; 13. Patients presenting with abnormal function of vital organs such as heart, brain or lungs, or the presence of clinically significant hydronephrosis, ascites or pericardial effusion, or being treated with thrombolytic therapy; 14. Women who are pregnant or breastfeeding; 15. Persons with personality or psychiatric disorders, civil incapacity or restricted civil capacity; 16. Currently participating in an interventional clinical study or have received other investigational drugs within 4 weeks prior to the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Overall survival;Duration of response;Safety;median time to response; | — |
Countries
China
Contacts
Public ContactXiang Yanqun
Sun Yat-Sen University Cancer Center
Outcome results
None listed