Clinical trial · Interventional
Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
Clinical Trial Phase I for Evaluation of Tolerability and Safety of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
- 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)
Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival probability of less than 5% when all stages are combined. At present, only approximately 10%-20% of patients are considered candidates for curative resection. The majority of patients (50%-60%) are present with metastatic disease, and substantial number of patients (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis. Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic cancer in phase I study. From the experience of prostatic cancer, the safety of combination with standard chemotherapy with Theragene treatment is 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Theragene®,Ad5-yCD/mutTKSR39rep-ADP | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Theragene arm
- description
- Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy
- interventionNames
- Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events assessed by CTCAE v4.03
- timeFrame
- 8 weeks
Secondary outcomes (5)
- measure
- Number of participants with treatment-related adverse events assessed by CTCAE v4.03
- timeFrame
- 12 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pancreatic cancer stage 3 * Patients with histologically confirmed pancreatic adenocarcinoma * Patients with no evidence of peritoneal or hematogenous metastasis * Patients with ECOG performance status 0-2 * 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 \< 2.5 times upper limit of normal (ULN)) * Patients with agreement with informed consent * Male patients with contraception Exclusion Criteria: * Female patients with childbearing age or pregnancy or breast feeding * Patients with a history of chemotherapy within 5 years * Patients with a history of radiation on more than 25% of bone marrow * Patients with unknown stage or recurrent pancreatic cancer * Patients with a history of skin cancer except malignant melanoma or malignancy except stage 0 cervical cancer * Patients with a history of major surgery except laparoscopic exam, endoscopic ultrasound, stenting, or PEG/PEJ placement * Patients with active or uncontrolled infection * Patients with immunosuppression or susceptibility to viral infection * Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis * Patients with a history of allergy to clinical trial medications * Patients who are considered as inappropriate candidate by investigators
References
Publications (1)
- DERIVEDLee JC, Shin DW, Park H, Kim J, Youn Y, Kim JH, Kim J, Hwang JH. Tolerability and safety of EUS-injected adenovirus-mediated double-suicide gene therapy with chemotherapy in locally advanced pancreatic cancer: a phase 1 trial. Gastrointest Endosc. 2020 Nov;92(5):1044-1052.e1. doi: 10.1016/j.gie.2020.02.012. Epub 2020 Feb 19. PMID 32084409