CClinicalTrials.gg
Status unknownNCT05114707Updated Nov 10, 2021

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

A Phase 2 interventional study of camrelizumab in Nasal Cavity Cancer, Paranasal Sinus Cancer and Camrelizumab, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-11-10.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2021, registered Oct 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nasal Cavity Cancer
  • Paranasal Sinus Cancer
  • Camrelizumab
  • Induction Chemotherapy
  • Intensity Modulated Radiotherapy
  • Concurrent Chemotherapy
03

In context

Paranasal Sinus Neoplasms

55 studies on the registry are indexed under Paranasal Sinus Neoplasms; 6 are open to participants now.

This study's planned enrollment of 57 is above the median of 32 across 48 interventional studies indexed under Paranasal Sinus Neoplasms.

Browse Paranasal Sinus Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (estimated)

Study arms

  • Experimental
    camrelizumab group

    Drug: camrelizumab

Interventions

  • Drugcamrelizumab

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

06

What researchers measure

Primary outcomes

  1. 3-year failure free survival

    time from the randomization to the first treatment failure or death

    Time frame: 3-year

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05114707
Lead sponsor
Sun Yat-sen University
Responsible party
Fei Han (professor, Sun Yat-sen University) — Principal investigator
First posted
Nov 10, 2021
Start date
Apr 16, 2021
Primary completion
Apr 16, 2024 (estimated)
Completion
Apr 16, 2024 (estimated)
Last update
Nov 10, 2021

Study contacts

Fei Han
Contact
hanfei@sysucc.org.cn
+86 13822113698
Pu-Yun OuYang
Contact
ouyangpy@sysucc.org.cn
+86 18565382769

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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