Status:
UNKNOWN
An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
NewGenPharm Incoporation
Conditions:
Pancreas Cancer
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief Summary
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. F...
Detailed Description
Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04739046
Start Date
February 1 2021
End Date
February 1 2024
Last Update
March 17 2021
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707