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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04739046

Enrollment

Registered

2021-02-04

Start date

2021-02-01

Completion date

2024-02-01

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer

Keywords

pancreatic cancer, radiation therapy, adenovirus, gene therapy

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. 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

Interventions

DRUGTheragene arm

Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate	24 weeks	the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response

Secondary

Measure	Time frame	Description
Disease control rate	24 weeks	the proportion of patients with advanced or metastatic cancer who have achieved complete response, partial response or stable disease
Tumor marker test	24 weeks	change of tumor marker in the process of assigned treatment
Overall survival	2 years	median time from beginning of treatment to death

Countries

South Korea

Contacts

Primary ContactJin-Hyeok Hwang, MD PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026