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
Overview
- Phase
- Phase 4
- Intervention
- rAd-p53 gene
- Conditions
- Advanced Malignant Thyroid Tumors
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Overall Response Rate
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Advanced stages of thyroid malignant tumors (stage III and VI)
- •At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
- •Histologically confirmed Oral and Maxillofacial malignant tumors
- •No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
- •Age: 18-85 years old
- •Expected to survive more 12 weeks
- •Neutrophils≥1.5×109/L,Platelet≥ 80×109/L, Hb≥80g/L, bilitubin≤2mg/dl,ALT and AST ≤2×institutional upper limit of normal, Cr ≤1.5×institutional upper limit of normal,coagulation tests (PTT and INR) within normal range
- •Subject provided signed informed consent -
Exclusion Criteria
- •Hypersensitive to study drug
- •Tumor(s) locate very close to important blood vessels and nerves, which affect injection
- •With a coagulation and bleeding disorder
- •With uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness
- •Local infection close to injection site or systemic infection
- •Pregnant or lactating
- •Principle investigator consider not suitable
Arms & Interventions
1
Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.
Intervention: rAd-p53 gene
2
surgery
Intervention: surgery
3
p53 gene therapy
Intervention: p53 gene therapy
4
p53 gene therapy plus radioactive iodine
Intervention: p53 gene therapy with radioactive iodine
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: 3 years
Secondary Outcomes
- Progress-free survival(3 years)