NCT03854838

IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma.

A Single Center 、Single Arm Phase I/II Clinical Trial of Intensity-modulated Radiotherapy Combined With Toripalimab in the Treating of Unresectable Locally Recurrent Nasopharyngeal Carcinoma.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of intensity-modulated radiation therapy combined with toripalimab in patients with the unresectable locally recurrent nasopharyngeal carcinoma.

Detailed description

This is an open-label ,single center ,non-randomized, single arm exploratory study. All eligible patients presented with non-keratinizing NPC and stage rT0-4N1-3M0 /rT2-4N0M0 are assigned to receive IMRT combined with toripalimab.

Conditions

• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Nasopharyngeal Diseases
• Head and Neck Neoplasm

Interventions

Type	Name	Description
DRUG	Tolipalimab	Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks) will be administered as an intravenous infusion over 60 minutes.
RADIATION	Reirradiation	intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-02-01
• Completion: 2023-02-01
• First posted: 2019-02-26
• Last updated: 2022-04-29

Locations

1 site across 1 country: China