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

Primary Purpose

Nasal Cavity Cancer, Paranasal Sinus Cancer, Camrelizumab

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
camrelizumab
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Cavity Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

camrelizumab group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 31, 2021
Last Updated
November 9, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05114707
Brief Title
Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses
Official Title
Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses: a Phase II Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
April 16, 2024 (Anticipated)
Study Completion Date
April 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Cavity Cancer, Paranasal Sinus Cancer, Camrelizumab, Induction Chemotherapy, Intensity Modulated Radiotherapy, Concurrent Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
camrelizumab group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
camrelizumab
Intervention Description
Camrelizumab was administrated with 200mg each time, every three weeks for a total of 11 cycles since the first day of induction chemotherapy.
Primary Outcome Measure Information:
Title
3-year failure free survival
Description
time from the randomization to the first treatment failure or death
Time Frame
3-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Han
Phone
+86 13822113698
Email
hanfei@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Pu-Yun OuYang
Phone
+86 18565382769
Email
ouyangpy@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Han, M.D.
Phone
+86 13822113698
Email
hanfei@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Pu-Yun OuYang, M.D.
Phone
+86 18565382769
Email
ouyangpy@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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