Squamous cell carcinoma of head and neck
Conditions
Interventions
experimental group:pabolizumab combined with cisplatin and paclitaxel in the neoadjuvant treatment
Sponsors
Cancer Hospital, Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage III-IV head and neck squamous cell carcinoma (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer and laryngeal cancer) diagnosed by histology and / or cytology; 2. The researchers believe that they can safely receive neoadjuvant therapy with pabolizumab combined with cisplatin and paclitaxel; 3. Aged 18 years and over; 4. ECOG 0-1; 5. RECIST v1. 1 defined measurable diseases.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received PD-1 monoclonal antibody or similar drugs; 2. No possible lesions for complete surgical resection: head and neck squamous cell carcinoma and / or distant metastasis of T4b; 3. Patients with history of other (including unknown primary) malignant tumors in the first 5 years. Note: except for fully treated stage 1 or 2 skin basal / squamous cell carcinoma or carcinoma in situ receiving potentially curative treatment; 4. Patients with known allergies to the study drug or its active ingredients or excipients; 5. The patient has any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient ischemia, myocardial infarction, congestive heart failure, severe arrhythmias requiring medical treatment, liver, kidney or metabolic disease; 6. Patients with underlying immunodeficiency, chronic infections, including HIV, hepatitis, tuberculosis (TB) or autoimmune diseases; 7. Patients with underlying hematological problems, including bleeding diathesis, known prior gastrointestinal bleeding requiring intervention within the past 6 months, and active pulmonary embolism or deep vein thrombosis (DVT) that is unstable in anticoagulation regiments; 8. Known history or any evidence of active NCD; 9. Simultaneous (or receiving) treatment with drugs that may affect drug metabolism for 7 days prior to day 1 of cycle 1; 10. Pregnant or lactating, or expecting to become pregnant or have a child within the predicted trial period; 11. Any serious medical or mental illness/condition, including substance use disorders, may interfere with or limit compliance with study requirements/treatment in the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete remission rate (PCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival, DFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactWang Xiaolei
Cancer Hospital, Chinese Academy of Medical Science
Outcome results
None listed