Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Radioactive Iodine , or Combination With Surgery in Subjects With Advanced Malignant Thyroid Tumors
Primary objectives of this study is to determine the efficacy profiles of rAd-p53
intra-tumor injection alone, with with concurrent radioactive iodine, or combination with
surgery for treatment of advanced malignant thyroid 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 radioactive iodine,or surgery.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Jingqiang Zhu, MD,PhD
Department Of Thyroid and breast Surgery, West China hospital, Sichuan University
China: Food and Drug Administration