Advanced Malignant Thyroid Tumors Clinical Trial
Official title:
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
This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of 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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment