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

Induction Chemotherapy Clinical Trial

Official title:

Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses: a Phase II Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114707
• Other study ID #: B2021-040-01
• Status: Recruiting
• Phase: Phase 2
• Start date: April 16, 2021
• Est. completion date: April 16, 2024

Study information

• Verified date: November 2021
• Source: Sun Yat-sen University
• Contact: Fei Han
• Phone: +86 13822113698
• Email: hanfei[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction Chemotherapy
• Nasal Cavity Cancer
• Paranasal Sinus Cancer
• Paranasal Sinus Neoplasms

Intervention

Drug:
• camrelizumab
Camrelizumab was administrated with 200mg each time, every three weeks for a total of 11 cycles since the first day of induction chemotherapy.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year failure free survival	time from the randomization to the first treatment failure or death	3-year