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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Paranasal Sinus Cancer; Induction Chemotherapy; Camrelizumab; Nasal Cavity Cancer; Intensity Modulated Radiotherapy; Concurrent Chemotherapy
• Intervention / Treatment: Drug: camrelizumab

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fei Han; Phone Number: +86 13822113698; Email: hanfei@sysucc.org.cn
• Study Contact Backup: Name: Pu-Yun OuYang; Phone Number: +86 18565382769; Email: ouyangpy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Fei Han, M.D.; Phone Number: +86 13822113698; Email: hanfei@sysucc.org.cn
      • Contact: Pu-Yun OuYang, M.D.; Phone Number: +86 18565382769; Email: ouyangpy@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: camrelizumab group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year failure free survival	time from the randomization to the first treatment failure or death	3-year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Anticipated): April 16, 2024
• Study Completion (Anticipated): April 16, 2024

Study Registration Dates

• First Submitted: October 31, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Nose Neoplasms; Paranasal Sinus Neoplasms
• Other Study ID Numbers: B2021-040-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No