Head and neck malignant tumors
Conditions
Interventions
PD-1 treatment observation group:None
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with malignant tumors of the head and neck (epithelial origin malignant tumors: squamous cell carcinoma, adenocarcinoma, etc.; mesenchymal origin malignant tumors: sarcoma, osteosarcoma, etc.); 2. The tumors are located in the oral and maxillofacial head and neck region (including the oral cavity, oropharynx, larynx, hypopharynx, salivary glands, maxillary sinuses, etc.); 3. ECGO score: 0-3 points; 4. The main organs have normal functions and can tolerate PD-1 immunotherapy: (1) The criteria for blood routine examination should meet: WBC >= 4.0×10^9/L, ANC >= 1.5×10^9/L, PLT >= 80×10^9/L, Hb >= 90g/L (without blood transfusion or blood products within 14 days, and without using G-CSF or other hematopoietic stimulating factors to correct); (2) The biochemical examination should meet the following criteria: serum albumin >= 3.0g/dL (30g/L), TBIL = 60ml/min (Cockcroft-Gault formula) (3) Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulation treatment, as long as the PT is within the range prescribed by the anticoagulant drug, it is acceptable. Note: or patients who have been evaluated by the investigator as being immunologically tolerable and whose benefits outweigh the risks can also participate in this cohort study. 5. Women of childbearing age should undergo pregnancy test (serum or urine) within 7 days before enrollment, and the result should be negative, and they are willing to use effective methods of contraception during the trial and within 2 months after the last administration of the trial drug treatment. For male subjects whose partners are women of childbearing age, effective contraception methods should be used during the trial and within 2 months after the last administration of the trial drug treatment; 6. Able to understand the content of the informed consent form, sign the informed consent form, and be willing to cooperate with relevant follow-up.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating female patients; 2.Severe liver disease (such as cirrhosis), kidney disease, respiratory system disease, hematological or endocrine system disease, uncontrolled disease; 3.The patient is infected with HIV, has active hepatitis B (HBV-DNA = 104 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCR-RNA is higher than the detection limit of the analytical method), and the disease is not controlled; 4.Within the first 6 months of enrollment, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA grade 2 or above heart failure, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure, with uncontrolled disease; Note: Patients who have been assessed by researchers as immune intolerant and whose treatment benefits outweigh the risks. 5.Patients with mental illnesses or known history of abuse or drug use of psychotropic substances; 6.Known to be allergic to the investigational drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies; 7.Patients who are unable to give consent and obtain the required amount of tumor tissue for pathological diagnosis and experimentation; 8.There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the study results, as well as patients deemed unsuitable by the researchers to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event; | — |
Countries
China
Contacts
Public ContactHe Yue
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed