drugset / Trial / NCT02429037

P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

NCT02429037 ↗

Phase 2 Unknown 60 enrolled Shenzhen SiBiono GeneTech Co.,Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.

Timeline

Start
2015-05
Primary completion
2018-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject rAd-p53 Unknown 2e+12 unknown Other
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous
Background Paclitaxel Small molecule 30 mg/m2 Intravenous

Indications