Hypopharyngeal cancer
Conditions
Interventions
Research group:Pembrolizumab 200mg D1/D22, nab-paclitaxel260mg/m2 D1/22, cisplatin 100 mg/m2 D1/22
Sponsors
The Sixth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Organized or cytology confirmed pharyngularized cell carcinoma under II-IVa, no regenerative / metastatic disease: 2. Has a pierced lesion; 3. The PD-L1 state is known, or the tumor tissue can be provided for PD-L1 detection; 4. ECOG rating 0-1 points; 5. The estimated survival time is more than 3 months; 6. The main organ function indicators meet the standards of conventional immunotherapy: Neutrophils absolute count >= 1.5 x 10^9 / L; platelet >= 100 x 10^9 / L; hemoglobin >= 100 g / L; serum albumin >= 30 g / L; bilirubin <= uln; alt and AST <= 2.5 x ULN If there is liver transfer, Alt and AST < 5 x ULN; serum creatinine <= 1.5 x ULN; blood urea nitrogen (BUN) <= 2.5 x normal upper limit (ULN); Promotecthyroid hormone (TSH) <= normal value upper limit (ULN); If an abnormality should be investigated, T3 and T4 levels, T3 and T4 can be selected. 7. The female subjects for childbearing age are willing to adopt high-efficiency contraceptive measures during the study; 8. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are not suitable for local treatment; 2. There is any active autoimmune disease or a history of autoimmune disease; 3. Received radiotherapy, chemotherapy, immunotherapy (PD-1 monoclonal antibody, PD-L1 monoclonal antibody, etc.) within 3.6 months; 4. Participated in other interventional clinical trials within 30 days before screening; 5. Patients with recurrence/metastasis; 6. History of other malignant tumors (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors cured for more than 3 years); 7. Poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 8. Known to be infected with HIV virus or active viral hepatitis; 9. Are receiving chronic steroid therapy for more than 6 months (such as prednisone dose > 10 mg/day or equivalent dose); 10. Those who are allergic to the drugs or their components used in this program; 11. Pregnant (confirmed by menstrual blood or urine HCG test) or breast-feeding women; 12. The researcher thinks that it is not suitable to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactWen Juyi
The Sixth Medical Center of PLA General Hospital
Outcome results
None listed