NCT06228079

Adjuvant vs Surgery Only in Early-stage Recurrent NPC

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Detailed description

This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial. Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

Conditions

• Recurrent Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Immunotherapy,Toripalimab Injection	Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
DRUG	Chemotherapy,Gemcitabine based regimen	Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

Timeline

• Start date: 2024-06-25
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2024-01-29
• Last updated: 2025-07-04

Locations

7 sites across 1 country: China