Camrelizumab, Concurrent Chemotherapy, Induction Chemotherapy, Intensity Modulated Radiotherapy, Nasal Cavity Cancer, Paranasal Sinus Cancer
Conditions
Brief summary
Patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. All the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-FU2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative intensity modulated radiotherapy. Besides, camrelizumab (200mg) is administrated every three weeks for a total of 11 cycles since the first day of induction chemotherapy. We aim to evaluate the three years failure free survival of these patients by the combination of camrelizumab with curative radiotherapy and chemotherapy.
Interventions
DRUGcamrelizumab
Camrelizumab was administrated with 200mg each time, every three weeks for a total of 11 cycles since the first day of induction chemotherapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* histologically confirmed squamous cancer of nasal cavity and paranasal sinuses * T4bN0-3M0 (AJCC8th) or unresectable lymph nodes or refusal of surgery * KPS≥70 * NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L * ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN * creatinine clearance rate ≥ 60 ml/min (calculated by Cockcroft-Gault)
Exclusion criteria
* older than 65 or younger than 18 * HBsAg (+) and HBV DNA \>1×10E3 copiers /mL * HCV (+) * HIV (+) * autoimmune diseases * interstitial lung diseases * had other cancers before
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year failure free survival | 3-year | time from the randomization to the first treatment failure or death |
Countries
China
Contacts
Primary ContactFei Han
Backup ContactPu-Yun OuYang
Outcome results
None listed