Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.

pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times

rAd-p53 gene

surgery

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

p53 gene therapy

p53 gene therapy with concurrent radioactive iodine pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

p53 gene therapy with radioactive iodine

aiqi wang, MD

Jingqiang Zhu, PhD, MD

Jingqiang Zhu, MD,PhD

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.

rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors	NCT00902122	Advanced Malign...	rAd-p53 gene surgery p53 gene therap... p53 gene therap...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors	NCT00902122	Advanced Malign...	rAd-p53 gene surgery p53 gene therap... p53 gene therap...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd

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