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

NCT03619824 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	UNKNOWN
Enrolment	40
Start date	2019-01
Completion	2024-03

Conditions

• Nasopharyngeal Neoplasms

Interventions

• Sintilimab
• Gemcitabine
• Cisplatin
• intensity-modulated radiotherapy

Primary outcomes

• Immune-related adverse events (irAEs) and serious adverse events (irSAEs) — From the date of informed consent to 100 days after treatment
  Graded according to CTCAE V5.0
• All adverse events (AEs) and serious adverse events (SAEs) — From the date of informed consent to 100 days after treatment
  Graded according to CTCAE V5.0

Countries

China