Clinical trial · Interventional
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
- 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)
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.
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 |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Theragene arm | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Theragene arm
- description
- Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy
- interventionNames
- Drug: Theragene arm
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 24 weeks
- description
- the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response
Secondary outcomes (3)
- measure
- Disease control rate
- timeFrame
- 24 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with borderline resectable or locally advanced pancreatic cancer * Patients with histologically confirmed pancreatic adenocarcinoma * Patients with no evidence of peritoneal or hematogenous metastasis * Patients with ECOG performance status 0-1 * Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²) * Patients with bone marrow function (WBC \> 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin \> 10 g/dL) * Patients with liver function (Bilirubin \< 2.0 mg/dL and SGOT and SGPT \< 3 times upper limit of normal (ULN)) * Patients with agreement with informed consent Exclusion Criteria: * Patients with a history of other cancer * Patients with recurred pancreatic cancer * Patients with a history of radiation on more than 25% of bone marrow * Patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy * Patients who have contraindication of radiation therapy * Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis * Female patients with childbearing age or pregnancy or breast feeding * Patients who are considered as inappropriate candidate by investigators
References
Publications (0)
Data not yet available