Clinical trial · Interventional
rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors
Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Chemotherapy, or Combination With Surgery in Subjects With Advanced Oral and Maxillofacial Malignant Tumors
NCT00902083CI-TRIAL-00006686rAd-p53unknownPhase 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 chemotherapy , or combination with surgery for treatment of advanced oral and maxillofacial malignant 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 Oral and Maxillofacial Malignant Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| p53 gene therapy | Drug | — | UNRESOLVED |
| p53 gene with surgery | Drug | — | UNRESOLVED |
| p53 with chemotherapy | Drug | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- surgery plus p53 gene
- description
- using p53 gene therapy before surgery
- interventionNames
- Drug: p53 gene with surgery
- type
- ACTIVE_COMPARATOR
- label
- surgery alone
- description
- Surgery without pre-p53 gene therapy
- interventionNames
- Procedure: surgery
- type
- EXPERIMENTAL
- label
- p53 plus chemotherapy
- description
- p53 gene therapy with concurrent chemotherapy
- 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 Oral and Maxillofacial 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.