Recurrent/metastatic HNSCC
Conditions
Interventions
treatment group:Finotonlimab combined with Stapokibart
Sponsors
Bejing Tongren Hospital, Capital Medical Uniersity
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the ICF; 2. Recurrent/metastatic HNSCC diagnosed histologically or cytologically in the oral, oropharyngeal, pharyngeal, and laryngeal regions; 3. Male/female, >= 18 years old, ECOG 0~1; 4. After PD-1 and platinum therapy, or PD-1 monotherapy, disease progression occurs within 12 weeks after the last ICI administration (as assessed by RECIST 1.1); 5. Target lesion (RECIST 1.1); 6. Previous PD-L1 expression test results may provide tissue for PD-L1 immunohistochemical testing; 7. Expected to survive for more than 3 months; 8. The main organ functions must meet the following requirements (laboratory test values within 7 days before enrollment must meet the following standards): (1) Blood routine examination: (No blood transfusion, no use of granulocyte colony-stimulating factor, no medication correction within 14 days before screening): a) Neutrophils >= 1.5 × 10^9/L; b) Platelets >= 75 × 10^9/L; c) Hemoglobin >= 90g/L; (2) Biochemical examination: (No albumin transfusion within 14 days before screening): a) Blood creatinine 50 mL/min; b) Serum total bilirubin <= 1.5 × ULN; c) Aspartate transaminase (AST) and alanine aminotransferase (ALT) <= 2.5 × ULN; (3) Coagulation function: a) International normalized ratio (INR) <= 2.3 or prothrombin time (PT) exceeding the normal control range <= 6 seconds.
Exclusion criteria
Exclusion criteria: 1. Suitable for local treatment; 2. Merge with other malignant tumors; 3. Brain metastasis; 4. If the toxicity does not recover to level 0-1 after surgery/radiotherapy/drug treatment, excluding chronic toxicity; 5. Allergic to known medication ingredients; 6. Major surgeries, radiation therapy (excluding palliative care), chemotherapy, immunotherapy, and biologics within 4 weeks prior to enrollment; 7. Received TKI, palliative surgery, and non-specific immunomodulatory therapy (such as thymosin and interferon) within 2 weeks before enrollment; 8. Received traditional Chinese patent medicines and simple preparations within one week before enrollment; 9. Use immunosuppressive drugs within 4 weeks before enrollment (excluding short-term, local, and physiological dose hormone therapy); 10. Patients with the following infection conditions: Active infections require systemic use of antibiotics; Active mycobacterium tuberculosis infection (i.e. tuberculosis infection); Hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus ribonucleic acid (HCV-RNA) positive; Hepatitis B virus deoxyribonucleic acid (HBV-DNA) >= 1000 IU/mL; History of human immunodeficiency virus (HIV) infection or HIV antibody positivity during screening period. 11. Uncontrollable pleural effusion, abdominal effusion, and pericardial effusion; 12. Previous grade >= 3 irAE or grade >= 2 myocarditis; 13. Have a serious history of cardiovascular and cerebrovascular diseases, including but not limited to: Major cardiovascular and cerebrovascular diseases (such as congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism, etc.) occurred within 6 months before the first administration; Corrected QT interval (QTcF)>480 milliseconds; Echocardiography (ECHO) indicates that the subject's left ventricular ejection fraction (LVEF) is less than 50%; New York Heart Association (NYHA) heart function classification >= 2; Clinically uncontrollable hypertension (note: diastolic blood pressure >= 100mmHg or systolic blood pressure >= 160mmHg. If blood pressure is controlled with or without intervention, subjects can continue to be screened); Other cardiovascular and cerebrovascular diseases that have been evaluated by the researchers as unsuitable for participation in this study; 14. Active autoimmune diseases; 15. There is a significant risk of bleeding; 16. Receive a live vaccine within 4 weeks before enrollment; 17. During pregnancy or lactation, subjects with fertility do not receive contraceptive measures; 18. The presence of mental illness may affect the conduct of clinical trials; 19. History of organ transplantation or stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Adverse Events (AEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Duration of Response;Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactZhang Luo
Bejing Tongren Hospital, Capital Medical Uniersity
Outcome results
None listed