Oropharyngeal cancer
Conditions
Interventions
Treatment group:Filonilimab, 200mg, every 3 weeks, 2-3 cycles + Cisplatin: 80mg/m^2, every 3 weeks, 2-3 cycles.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Patients diagnosed with oropharyngeal cancer by pathological histology, the investigator believes the patient is not suitable for surgery or the patient refuses surgery, immunohistochemical P16 positive or negative, 8th edition AJCC oropharyngeal cancer TNM staging T1-4N0-3M0; 3. Tumor expresses PD-L1, CPS >= 1; 4. According to the RECIST 1.1 standard, there must be at least one measurable tumor lesion, and the measurable target lesion should not have received local treatment such as radiotherapy; 5. Eastern Cooperative Oncology Group (ECOG) PS score: 0-1 points; 6. Expected survival period >= 3 months; 7. Normal major organ function, that is, meeting the following criteria: Blood routine examination criteria need to meet: (within 14 days before screening, no blood transfusion or blood products) 1) HB >= 90g/L; 2) ANC >= 1.5×10^9/L; 3) PLT >= 75×10^9/L; Biochemical examination needs to meet the following criteria: (within 14 days before screening, no blood transfusion or blood products) 1) BIL = 50ml/min (Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 50%. 8. Pregnant women of childbearing age must have taken reliable contraceptive measures, or within 7 days before enrollment, undergo a pregnancy test (serum or urine), and the result is negative, and are willing to use effective methods of contraception during the treatment period and within 2 months after the treatment; 9. Participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Participants who received local treatments such as radiotherapy or other immunotherapies within 4 weeks before the start of the study; 2. Pregnant or breastfeeding, or planning to become pregnant during the study period; 3. Have a history of any active autoimmune disease or illness (including any history of inflammatory bowel disease), or a syndrome history requiring systemic steroid or immunosuppressive drug treatment, except for patients with vitiligo or asthma/allergic diseases; 4. Have active infections or infectious diseases that require systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection, etc.; 5. Have a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6. Have any severe and / or uncontrolled diseases, such as: 1) Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before screening, severe uncontrolled arrhythmia; 2) Active or uncontrolled severe infections; 7. Liver diseases such as decompensated liver cirrhosis, untreated chronic hepatitis B carrier or active hepatitis C carrier. Note: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL) and cured hepatitis C patients can be included; 8. According to the investigator's judgment, there are other patients with serious accompanying diseases that endanger the safety of the patients or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate;1-year overall survival rate;2-year overall survival rate;2-year overall survival rate;Progress Free Survival;Duration of Response;disease control rate;Adverse Event; | — |
Countries
China
Contacts
Public ContactXin Jiang
The First Hospital of Jilin University
Outcome results
None listed