Clinical trial · Interventional
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
NCT00902122CI-TRIAL-00006682unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Thyroid Tumors | Malignant Thyroid Gland Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| p53 gene therapy | Drug | — | UNRESOLVED |
| p53 gene therapy with radioactive iodine | Radiation | — | UNRESOLVED |
| rAd-p53 gene | Drug | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1
- description
- Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.
- interventionNames
- Drug: rAd-p53 gene
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- surgery
- interventionNames
- Procedure: surgery
- type
- EXPERIMENTAL
- label
- 3
- description
- p53 gene therapy
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Advanced stages of thyroid malignant tumors (stage III and VI) 2. At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm 3. Histologically confirmed Oral and Maxillofacial malignant tumors 4. No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks 5. Age: 18-85 years old 6. Expected to survive more 12 weeks 7. ECOG:0-2 8. 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 9. Subject provided signed informed consent - Exclusion Criteria: 1. Hypersensitive to study drug 2. Tumor(s) locate very close to important blood vessels and nerves, which affect injection 3. With a coagulation and bleeding disorder 4. 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 5. Local infection close to injection site or systemic infection 6. Pregnant or lactating 7. Principle investigator consider not suitable
References
Publications (0)
Data not yet available
No reference posted for this study.