Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 4:28 PM
Study NCT ID:
NCT07110558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PUPA
Brief 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.
Detailed Description:
The goals of this clinical trial includes: ① To assess the regional relapse-free survival (RRFS) and safety after radiotherapy without prophylactic neck irradiation in combination with neoadjuvant and adjuvant PD-1 antibody toripalimab and cisplatin concurrent chemotherapy for N0-1 (restricted to retropharyngeal lymph nodes) patients with nasopharyngeal carcinoma; ② To evaluate the impact of radiotherapy without prophylactic neck irradiation on 2-year overall survival (OS), 2-year progress-free survival (PFS), 2-year distant metastasis-free survival (DMFS), and 2-year locoregional relapse-free survival (LRRFS) for N0-1 ( limited to retropharyngeal lymph nodes) patients with nasopharyngeal carcinoma; ③ To explore the impact of radiotherapy without prophylactic neck irradiation on toxicities and quality of life; ④ To explore the relationship between clinical factors and the impact of neoadjuvant and adjuvant PD-1 antibody, radiotherapy without prophylactic neck irradiation on the survival of patients; ⑤ To explore the biomarkers of sensitivity to immunotherapy, chemotherapy and radiotherapy for patients with nasopharyngeal carcinoma and the underlying mechanism.
For these purposes, we plan to prospectively enroll T2N0-1 and primary gross tumor volume (GTV) greater than 30.0 cm3 or T3-4N0-1 stage NPC patients, whose N1 restricted to retropharyngeal lymph nodes from one center in China. The patients will receive 2 cycles of neoadjuvant PD-1 antibody (toripalimab monotherapy, 240 mg, every two weeks, intravenous infusion) followed by concurrent cisplatin (100 mg/m2 intravenously) on days 1, 22, and 43 during intensity-modulated radiotherapy (IMRT), and adjuvant toripalimab (240 mg intravenously) once every 3 weeks for up to eight cycles. All participants will be treated with IMRT restricted to primary tumor without prophylactic neck irradiation. The clinical outcomes, safety, complications, and quality of life will be explored in the RT without prophylactic neck irradiation.
For these purposes, we plan to prospectively enroll T2N0-1 and primary gross tumor volume (GTV) greater than 30.0 cm3 or T3-4N0-1 stage NPC patients, whose N1 restricted to retropharyngeal lymph nodes from one center in China. The patients will receive 2 cycles of neoadjuvant PD-1 antibody (toripalimab monotherapy, 240 mg, every two weeks, intravenous infusion) followed by concurrent cisplatin (100 mg/m2 intravenously) on days 1, 22, and 43 during intensity-modulated radiotherapy (IMRT), and adjuvant toripalimab (240 mg intravenously) once every 3 weeks for up to eight cycles. All participants will be treated with IMRT restricted to primary tumor without prophylactic neck irradiation. The clinical outcomes, safety, complications, and quality of life will be explored in the RT without prophylactic neck irradiation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: