Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group: Toripalimab 240mg+TP regimen(Albumin-bound Paclitaxel, 260mg/m2
or Paclitaxel liposome 175mg/m2+Nedaplatin 80mg/m2) D1 Q3W, 2 cycles.
Sponsors
Shandong Second Provincial General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years and =75 years; 2. ECOG score =1 3. Histopathologically confirmed hypopharyngeal carcinoma, cervical esophageal carcinoma; 4. Patients with primary surgical approach of total laryngectomy or no indication for surgery, stage IIIIV, and some T2 patients with hypopharyngeal cancer can also be enrolled if they are indicated for total laryngectomy. 5. No previous treatment, including radiotherapy, chemotherapy, immunotherapy or biological therapy. 6. At least one measurable lesion according to RECIST v 1.1 7. Life expectancy is at least 6 months. 8. No contraindications to chemotherapy or immunotherapy; 9. Before the first dose of drugs for study, patients should have appropriate organ function and the laboratory results must meet conditions as following: Hematology: white blood cells =3.0×10^9/L, neutrophil absolute value (ANC) =2.0×10^9/L, hemoglobin =90g/L,platelet count =100×10^9/L,Serum albumin = 2.8 g/dL. Liver function: total bilirubin is lower than 1.5 times the maximum normal value; ALT and AST are lower than 3 times the maximum normal value. Serum creatinine = 1.5xULN or creatinine clearance > 60 mL/min. 10. Female subjects of childbearing potential, as well as male subjects with partners of childbearing potential, need to use a medically recognized contraceptive (such as uterine energy, internal contraceptive devices, contraceptives, or condoms) during study treatment, and at least 3 months after the last use of toripalimab and at least 6 months after the last use of chemotherapy or radiotherapy; 11. Subjects voluntarily join this study, and signed informed consent, with good compliance, can cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. History of severe hypersensitivity to other monoclonal antibodies or to any component of PD-1 monoclonal antibodies; 2. Other concurrent uncontrolled malignancy. 3. Concurrent severe psychiatric disease; 4. Patients with severe heart disease, pulmonary dysfunction, cardiac function and pulmonary function lower than grade 3 (including grade 3); 5. Laboratory test values within 7 days before enrollment that do not meet the relevant criteria; 6. Systemic or local glucocorticoid therapy within 4 weeks prior to enrollment; 7. Patients with comorbidities requiring chronic immunosuppressive drug therapy or systemic or local corticosteroids at immunosuppressive doses; 8. Patients with active pulmonary tuberculosis (TB) who are receiving anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening; 9. HIV positive; 10. HBsAg positive and HBV DNA copy number positive (quantitative detection = 1000cps/ml or IU/ml); chronic hepatitis C blood screening positive (HCV antibody positive); 11. Women of childbearing potential with positive pregnancy test and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathologic Response Rate;Overall Response Rate;2-year EFS rate;2-year OS rate;Safety; | — |
Countries
China
Contacts
Public ContactYumei Wei
Shandong Second Provincial General Hospital
Outcome results
None listed