NCT03619824

PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma

Neoadjuvant Sintilimab (PD-1 Antibody)-Chemotherapy and Concurrent Sintilimab-chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Phase 2 Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial plans to enroll 40 patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (NPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 6 cycles.

Conditions

• Nasopharyngeal Neoplasms

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg ivdrip, every 3 weeks for 6 cycles
DRUG	Gemcitabine	Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
DRUG	Cisplatin	Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
RADIATION	intensity-modulated radiotherapy	Definitive IMRT of 66-70Gy will be given in six to seven weeks.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-10-01
• Completion: 2024-03-01
• First posted: 2018-08-08
• Last updated: 2018-10-09

Locations

1 site across 1 country: China