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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05114707
Other study ID # B2021-040-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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