NCT06912711

TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma

Toripalimab Combined With Nimotuzumab Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma：A Single-arm, Phase II Clinical Tria

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Investigators target recurrent nasopharyngeal carcinoma that can be resected surgically: rT1, rT2 (tumor confined to the surface of the parapharyngeal space, greater than 0.5cm from the internal carotid artery), rT3 (confined to the floor of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage), A single-arm, phase II clinical trial was designed to investigate the efficacy and safety of triplizumab combined with nituzumab in induction and adjuvant treatment of operable local recurrent nasopharyngeal carcinoma.

Detailed description

Investigators target recurrent nasopharyngeal carcinoma that can be resected surgically: rT1, rT2 (tumor confined to the surface of the parapharyngeal space, greater than 0.5cm from the internal carotid artery), rT3 (confined to the floor of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage), A single-arm, phase II clinical trial was designed to investigate the efficacy and safety of triplizumab combined with nituzumab in induction and adjuvant treatment of operable local recurrent nasopharyngeal carcinoma. The investigators focus on the 2-year PFS as the primary outcome.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	Triplizumab (240mg, Q3W, 2 cycles, induction)and (240mg, Q3W, 15 cycles, adjuvant)
DRUG	Nimotuzumab	Triplizumab (200mg, Q3W, 2 cycles, induction) and (200mg, Q3W, 15 cycles, adjuvant)
PROCEDURE	surgery	The complete resection of the nasopharyngeal tumor and its adequate safety boundary must be performed under general anesthesia and under the guidance of nasal endoscopy through bilateral nasal passages. The anterior incisal margin should reach 1-2cm in front of the posterior column of the nasal septum, and the upper incisal margin should reach about 0.5-1cm in front of the upper margin of the posterior nostril. The lateral incisal margin and the lower incisal margin should be individually designed according to the size and location of the tumor. A safe incisal margin of 0.5-1.0cm was obtained, and then the tumor tissue and normal tissue of the incisal margin were ablated layer by layer from the upper incisal margin to the lower incisal margin until no obvious tumor remained under the naked eye.

Timeline

• Start date: 2025-05-16
• Primary completion: 2029-04-20
• Completion: 2029-04-20
• First posted: 2025-04-06
• Last updated: 2025-05-21

Locations

1 site across 1 country: China