NCT06235203

Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy

Detailed description

Eligible patients are randomized into the control group and the experimental group. Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy. Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.

Conditions

• Recurrent Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	endoscopic surgery	The tumor was resected by endoscopic nasopharyngectomy.
DRUG	Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy	Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.
DRUG	Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy	Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.
DRUG	Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy	Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.

Timeline

• Start date: 2024-07-09
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-01-31
• Last updated: 2025-06-03

Locations

7 sites across 1 country: China