squamous cell carcinoma
Conditions
Interventions
Interventions group:Interferon ? combined with camrelizumab and chemotherapy
Sponsors
Hefei Cancer Hospital, Chinese Academy of Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Male or female, age = 18 years; 3. Histologically confirmed squamous cell carcinoma; 4. ECOG score 0-1 points; 5. Expected survival time> 6 months; 6. Adequate organ function, subjects need to meet the following laboratory indicators: 7. Absolute neutrophil value (ANC) > = 1.5x10?/L without the use of granulocyte colony-stimulating factor in the last 14 days; 8. In the absence of blood transfusion in the past 14 days, platelet 9g/dL; 10. Liver function: total bilirubin =1.5× upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were 50mL/min (Cockcorft-Gault formula); Qualitative urine protein =60 ml/min; 12. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 13. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 14. Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 15. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 16. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapeutic agent).
Exclusion criteria
Exclusion criteria: 1. Currently participating in an interventional clinical research treatment, or having received other investigational drugs or been treated with investigational devices within 4 weeks before the first administration; 2. Having received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration; 3. Having had an active autoimmune disease within 2 years before the first administration that required systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants). Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 4. Receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled, or other routes of local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; 5. Note: The use of physiological doses of glucocorticoids (= 10 mg/day of prednisone or equivalent drugs) is allowed; 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Known to be allergic to the drugs used in this study; 8. Not having fully recovered from the toxicity and/or complications caused by any intervention before starting the treatment (i.e., = Grade 1 or returning to the baseline, excluding fatigue or hair loss); 9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 10. Untreated active hepatitis B (defined as positive for HBsAg and the detected HBV-DNA copy number being higher than the upper limit of the normal value in the clinical laboratory of the research center); Note: Hepatitis B subjects meeting the following criteria can also be enrolled: 1) The HBV viral load is < 2500 copies/ml (500 IU/ml) before the first administration, and the subjects should receive anti-HBV treatment throughout the chemotherapy drug treatment period of the study to avoid viral reactivation. 2) For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have a negative HBV viral load, they do not need to receive preventive anti-HBV treatment, but they need to be closely monitored for viral reactivation. 11. Subjects with active HCV infection (positive for HCV antibody and the HCV-RNA level is higher than the lower limit of detection); 12. Having received a live vaccine within 30 days before the first administration (Cycle 1, Day 1); 13. Note: Receiving an inactivated viral vaccine for seasonal influenza by injection within 30 days before the first administration is allowed; however, receiving a live attenuated influenza vaccine administered intranasally is not allowed. 14. Pregnant or lactating women; 15. Having any severe or uncontrollable systemic diseases, such as: 1) Significant and severely symptomatic and uncontrollable abnormalities in the rhythm, conduction, or morphology of the resting electrocardiogram, such as complete left bundle branch block, cardiac conduction block of Grade II or above, ventricular arrhythmia, or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class = 2; 3) Having experienced any arterial thrombosis, embolis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief;Progression-free survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactDandan Wei
Hefei Cancer Hospital, Chinese Academy of Sciences
Outcome results
None listed