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

Phase 2

• Conditions: Induction Chemotherapy; Paranasal Sinus Cancer; Intensity Modulated Radiotherapy; Camrelizumab; Nasal Cavity Cancer; Concurrent Chemotherapy
• Interventions: Drug: camrelizumab

• Registration Number: NCT05114707
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-16
• Study First Submitted: 2021-10-31
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-09
• Last Update Submitted: 2021-11-09
• Study First Posted: 2021-11-10
• Last Update Posted: 2021-11-10
• Primary Completion: 2024-04-16
• Study Completion: 2024-04-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
camrelizumab group	camrelizumab	-

Primary Outcome Measures

Name	Time	Method
3-year failure free survival	3-year	time from the randomization to the first treatment failure or death

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China