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NOT YET RECRUITING
NCT04605562
PHASE2

Umbrella Biomarker-Guided Therapy in NPC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2022-06

Completion Date

2026-12

Last Updated

2021-09-05

Healthy Volunteers

No

Interventions

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China