Squamous cell carcinoma of head and neck
Conditions
Interventions
experimental group:Adjuvant therapy with pabolizumab
Sponsors
Cancer Hospital Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. After comprehensive treatment including radiotherapy / concurrent chemoradiotherapy, the persistent / recurrent head and neck squamous cell carcinoma was evaluated. There were high-risk factors in the pathological results after salvage surgery (positive margin, extracapsular invasion of lymph nodes, peripheral nerve invasion, vascular tumor thrombus, more than 2 metastatic lymph nodes, pathological rt3-4a / N2-3); 2. Voluntarily participate in this clinical study and sign informed consent; 3. No gender limitation, age 18 years and over; 4. ECOG 0-1; 5. The estimated postoperative survival is more than 6 months; 6. Women should agree that they must use contraception (such as an intrauterine device (IUD), birth control pills, or condoms) during and within 6 months after the study; Had a negative serum or urine pregnancy test within 7 days before study enrollment and had to be non-lactating; Men should agree to use contraception during the study and within 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1. There is no clear high-risk pathological factor in the postoperative pathological evaluation of patients with predictive consent; 2. Patients with potential hematological problems, including bleeding quality, known previous gastrointestinal bleeding requiring intervention in the past 6 months, and active pulmonary embolism or deep venous thrombosis (DVT) is unstable in the anticoagulation regimen; 3. Known history or any evidence of active NCD; 4. Known active central nervous system (CNS) metastases and/or cancerous meningitis or leptomeningiosis. Subjects with previous treatment of brain metastases can participate in, as long as they are stable (in the first trial treatment at least four weeks before the latest developments in imaging evidence and no nervous system symptoms has returned to baseline), there is no new or expanding evidence of brain metastasis, and at least 7 days before the experimental treatment not steroid use. The exception does not include cancer meningitis, which is excluded regardless of clinical stability; 5. Simultaneous (or receiving) treatment with drugs that may affect drug metabolism for 7 days prior to day 1 of cycle 1; 6. Pregnant or lactating, or expecting to become pregnant or have a child within the predicted trial period; 7. Any uncontrolled co-morbid conditions, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmias; 8. When screening EKG > 475 ms, the corrected QT (QTc) interval was extended; 9. Ejection fraction < 40% by 2D echocardiography (ECHO) at screening; 10. Any serious medical or mental illness/condition, including substance use disorders, that may interfere with or limit compliance with study requirements/treatment in the investigator's judgment; 11. Has an active autoimmune disease that has required systemic treatment (i.e., use of disease modulators, corticosteroids, or immunosuppressive drugs) in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant Failure-Free Survival, DFFS;Local failure free survial, LFFS;Overall Survival, OS;Quality of Life; | — |
Countries
China
Contacts
Public ContactWang Xiaolei
Cancer Hospital Chinese Academy of Medical Science
Outcome results
None listed