RecruitingPhase 2NCT06912711

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

Sponsor

Sun Yat-sen University

Enrollment

70 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach — induction therapy followed by surgery and additional treatment — for people with nasopharyngeal carcinoma (cancer at the back of the nasal cavity) that has come back after previous radiation therapy. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed recurrence of nasopharyngeal carcinoma, at least 6 months after finishing radiation - Your cancer is classified as a type that can potentially be surgically removed (certain early recurrence stages) - Your overall health is good and blood counts are adequate **You may NOT be eligible if...** - Your cancer type is keratinized squamous cell carcinoma (a specific rare subtype) - You have had another clinical trial treatment within the last 3 months - You have had an organ transplant or bone marrow transplant - You received steroid medications in the last 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

Triplizumab (240mg, Q3W, 2 cycles, induction)and (240mg, Q3W, 15 cycles, adjuvant)

DRUGNimotuzumab

Triplizumab (200mg, Q3W, 2 cycles, induction) and (200mg, Q3W, 15 cycles, adjuvant)

PROCEDUREsurgery

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.