Clinical trial · Interventional
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
- 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)
The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects. The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery | Procedure | — | UNRESOLVED |
| Surgery combined with rAd-p53 gene therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery plus post-surgery chemotherapy
- description
- Surgery plus post-surgery chemotherapy
- interventionNames
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- Surgery combined with rAd-p53 gene therapy
- description
- Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy
- interventionNames
- Drug: Surgery combined with rAd-p53 gene therapy
Primary outcomes (2)
- measure
- overall survival
- timeFrame
- 3 year after the treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * historically diagnosed advanced non-small lung cancer * has surgery indication * age 18 years old or greater * life expectancy greater than 12 weeks * ECOG: 0-2 * no prior chemotherapy, radiotherapy in 2 weeks * Neutrophils≥1.5×10\^9/L,platelet≥80×10\^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range * subject provides signed informed consent Exclusion Criteria: * hypersensitive to study drug * with a coagulational test unnormal or a bleeding disorder * infections * with serious condition which can't stand a surgery * pregnant or lactating * principle investigator consider not suitable
References
Publications (0)
Data not yet available