An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy
NCT ID: NCT04739046
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
12 participants
INTERVENTIONAL
2021-02-01
2024-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Theragene arm
Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy
Theragene arm
Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy
Interventions
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Theragene arm
Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
75 Years
ALL
No
Sponsors
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NewGenPharm Incoporation
UNKNOWN
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Principal Investigators
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Jin-Hyeok Hwang, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Jin-Hyeok Hwang, MD PhD
Role: primary
Other Identifiers
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SNUBH-IMGPB-2021-02
Identifier Type: -
Identifier Source: org_study_id
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