Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Therapy Combined With Chemotherapy and Radiotherapy in Treament of Head and Neck Cancer in Advanced Stage
Primary objectives of this study is to determine the efficacy profiles of rAd-p53
intra-tumor injection alone, with concurrent chemotherapy, with concurrent radiotherapy, or
combination with surgery for treatment of head and neck malignant tumors in advanced stage
(stage III or IV) including target lesion complete response rate (LCR) and overall target
lesion response rate (OLR), response duration (RD), and progress-free survival (PFS).
The secondary objectives of this study is to investigate overall response rate (OPCR) and
overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53
monotherapy and combined with chemotherapy, radiotherapy or surgery.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
China: Food and Drug Administration