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An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT04739046•Seoul National University Bundang Hospital

View on ClinicalTrials.gov

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. 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

Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy

Eligibility

Age

19 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Key Dates

Start Date

February 1, 2021

Primary Completion Date

August 1, 2022

Completion Date

February 1, 2024

Last Updated

March 17, 2021

Enrollment

ESTIMATED participants

Conditions

Pancreas Cancer

Interventions

Theragene arm

DRUG

Contacts

Jin-Hyeok Hwang, MD PhD

CONTACT

+82-31-787-7017 wooltong@snu.ac.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy

Inclusion Criteria

Exclusion Criteria

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