NCT04605562

Umbrella Biomarker-Guided Therapy in NPC

Precision Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma Based on Molecular Immune Subtyping: an Umbrella Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, open-label, umbrella study, with the purpose to evaluate the therapeutic efficacy and safety of chemoradiotherapy in combination with immunotherapy and/or targeted treatment in high-risk locoregionally advanced nasopharyngeal carcinoma. The specific grouping of patients' depends on the SYSUCC immune subtyping based on 100+ gene panel testing.

Detailed description

This is a phase 2, open-label, umbrella study, with the purpose to evaluate the therapeutic efficacy and safety of chemoradiotherapy in combination with immunotherapy and/or targeted treatment in high-risk locoregionally advanced nasopharyngeal carcinoma. The specific grouping of patients' depends on the SYSUCC immune subtyping based on 100+ gene panel testing. The molecular subgroups include the Active, Evaded and non-Immune Subtypes. New treatment arms may be added and/or existing treatment arms may be closed during the study course on the basis of ongoing efficacy and safety as well as the current treatments available.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	GP+DDP	Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles; induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
DRUG	Palbociclib	Administered orally
RADIATION	Intensity-modulated radiotherapy	Definitive IMRT of 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day
DRUG	PD-1 blocking antibody	Administered every 3 weeks
DRUG	Galunisertib	Administered orally

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-10-28
• Last updated: 2021-09-05

Locations

1 site across 1 country: China