Sintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma: a Randomized, Multicenter, Phase 3 Trial (CONTINUUM)

NCT03700476 Phase 3 UNKNOWN

The CONTINUUM trial plans to enroll patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or the same regimen plus Sintilimab. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 12 cycles.

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	UNKNOWN
Enrolment	425
Start date	2018-12-21
Completion	2025-01

Conditions

• Nasopharyngeal Neoplasms

Interventions

• Sintilimab
• Gemcitabine
• Cisplatin
• intensity-modulated radiotherapy

Primary outcomes

• Event-free survival (EFS) — 3 years
  calculated from randomization to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.

Countries

China