Clinical trialPhase 2Unknown
An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy
A Single Arm, Open, Exploratory Clinical Trial to Evaluate Efficacy and Safety for Combination Treatment of Replication Competent Adenovirus Double Suicide Gene Therapy(Theragene®,Ad5-yCD/mutTKSR39rep-ADP) and Radiation Therapy in Patients
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- 1 February 2021
- Expected end
- 1 February 2024
- Enrollment
- 12 participants
- Sites
- 1
- Primary outcomes
- Objective Response Rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 17 March 2021
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Brief summary public domain (ClinicalTrials.gov)
Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed safety and anti-cancer effect in patients with pancreatic cancer in phase I study. From the experience of phase I study, the safety and efficacy of combination with standard chemotherapy and radiation therapy with Theragene treatment will be assessed in this study.
Detailed description public domain (ClinicalTrials.gov)
Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy