Clinical trial · Interventional
P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer
Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study
NCT02429037CI-TRIAL-00017677unknownPhase 2ClinicalTrials.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)
The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.
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 Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| radiation | Radiation | — | UNRESOLVED |
| rAd-p53 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- rAd-p53 plus radiation and chemotherapy
- description
- rAd-p53 tumor injection combined with radio- and chemo-therapy.
- interventionNames
- Drug: rAd-p53
- Radiation: radiation
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- radiation and chemotherapy
- description
- radiation combined with chemotherapy
- interventionNames
- Radiation: radiation
- Drug: Cisplatin
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. histopathologically diagnosed head and neck cancer; 2. unresectable, locally advanced; 3. 18 years or older; 4. with an Eastern Cooperative Oncology Group (ECOG) score of 0-2; 5. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form. Exclusion Criteria: 1. Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L; 2. have serious heart, lung function abnormalities or severe diabetes patients; 3. active infection; 4. severe atherosclerosis; 5. AIDS patients; 6. serious thrombotic or embolic events within 6 months; 7. renal insufficiency requiring hemodialysis or peritoneal dialysis; 8. pregnant or lactating women; 9. mental disorder or disease.
References
Publications (0)
Data not yet available
No reference posted for this study.