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

NCT05114707 | Unknown Phase 2

• 1 other identifier: B2021-040-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 3-year failure free survival

  time from the randomization to the first treatment failure or death

  3-year

Study Arms (1)

camrelizumab group

EXPERIMENTAL

Drug: camrelizumab

Interventions

camrelizumab DRUG

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

camrelizumab group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Paranasal Sinus Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Nose Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Central Study Contacts

Fei Han

CONTACT

+86 13822113698; hanfei@sysucc.org.cn

Pu-Yun OuYang

CONTACT

+86 18565382769; ouyangpy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 10, 2021
• Study Start: April 16, 2021
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)