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

NCT ID: NCT05114707

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2024-04-16

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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camrelizumab group

Group Type EXPERIMENTAL

camrelizumab

Intervention Type DRUG

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

Interventions

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camrelizumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Fei Han

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fei Han

Role: CONTACT

Phone: +86 13822113698

Email: [email protected]

Pu-Yun OuYang

Role: CONTACT

Phone: +86 18565382769

Email: [email protected]

Facility Contacts

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Fei Han, M.D.

Role: primary

Pu-Yun OuYang, M.D.

Role: backup

Other Identifiers

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B2021-040-01

Identifier Type: -

Identifier Source: org_study_id