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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Intensity Modulated Radiotherapy; Paranasal Sinus Cancer; Induction Chemotherapy; Nasal Cavity Cancer; Concurrent Chemotherapy; Camrelizumab

Treatments: Drug: camrelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05114707

B2021-040-01

Details and patient eligibility

About

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.

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

camrelizumab group

Experimental group

Treatment:

Drug: camrelizumab