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NOT YET RECRUITING
NCT07110558
PHASE2

Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This single-arm, phase 2 trial evaluates the efficacy and safety of de-escalated radiotherapy (restricted to the primary tumor, omitting prophylactic neck irradiation) combined with neoadjuvant and adjuvant toripalimab immunotherapy, and concurrent chemotherapy in patients with nasopharyngeal carcinoma staged N0 or N1, where nodal involvement is strictly confined to the retropharyngeal lymph nodes.

Official title: A Single-arm, Phase II Trial of Radiotherapy Without Prophylactic Neck Irradiation in Combination With Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab for Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2025-08-15

Completion Date

2032-08-14

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

RADIATION

Without prophylactic neck irradiation

Intensity-modulated radiotherapy restricted to the primary tumor, omitting prophylactic neck irradiation.

DRUG

PD-1 antibody (Toripalimab)

Toripalimab 240mg every 2 weeks with a total of 2 cycles as neoadjuvant anti-PD-1 immunotherapy; Toripalimab 240mg every 3 weeks with a total of 8 cycles as adjuvant anti-PD-1 immunotherapy after CCRT

DRUG

Cisplatin

Cisplatin 100mg/m2(every three weeks), Day 1, Day 22, Day 43 of intensity modulated radiotherapy

Locations (1)

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, China