Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Chemotherapy, or Combination With Surgery in Subjects With Advanced Oral and Maxillofacial Malignant Tumors
Primary objectives of this study is to determine the efficacy profiles of rAd-p53
intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for
treatment of advanced oral and maxillofacial malignant tumors(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,or surgery.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall best response rate
Longjiang Li, PhD, MD
West China Hospital
China: Food and Drug Administration