Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses

• Status: Recruiting
• Trial end date: 2024-04-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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