NCT05340270

PD-1 Inhibitor Plus GP as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma

PD-1 Inhibitor Plus GP Chemotherapy as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II, Multicenter, Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase II, Multicenter, Randomized Controlled Clinical Trial is to evaluate the efficacy and safety of PD-1 inhibitor Plus GP chemotherapy as Neoadjuvant Therapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma.

Detailed description

Induction chemotherapy plus concurrent chemoradiotherapy has the IIA evidence and the gemcitabine plus cisplatin (GP) regimen has the I evidence in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). More and more evidence shows that immunotherapy combined with chemotherapy has a synergistic effect in treating tumors. GP chemotherapy combined with PD-1 inhibitor has achieved the initial effect in NPC. With the development of radiotherapeutic techniques and equipment as well as advances in treatment modalities, the 5-year overall survival of patients with non-disseminated NPC has exceeded 80%. But there are still about 20-30% of NPC patients who experienced recurrence or metastasis after radical chemoradiotherapy, especially locoregionally advanced patients. In order to improve their survival, we conduct this clinical trial to determine whether GP chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy can improve the failure-free survival rate of locoregionally advanced NPC patients and provide new evidence for their neoadjuvant therapy of them.

Conditions

• Nasopharyngeal Carcinoma
• Neoadjuvant Therapy
• PD-1 Inhibitor

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor+GP	PD-1 inhibitor (200-240mg), gemcitabine (1000mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1) every three weeks for three cycles as neoadjuvant therapy, then followed by IMRT and cisplatin (100mg/m2, d1, 22, 43 of RT) during concurrent chemoradiotherapy.
DRUG	GP	Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1) every three weeks for three cycles as neoadjuvant therapy, then followed by IMRT and cisplatin (100mg/m2, d1, 22, 43 of RT) during concurrent chemoradiotherapy.

Timeline

• Start date: 2022-07-15
• Primary completion: 2026-03-29
• Completion: 2029-03-29
• First posted: 2022-04-22
• Last updated: 2025-12-11

Locations

1 site across 1 country: China