NCT04739046

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 17, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

February 1, 2021

Last Update Submit

March 15, 2021

Conditions

Pancreas Cancer

Keywords

pancreatic cancerradiation therapyadenovirusgene therapy

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response

    24 weeks

Secondary Outcomes (3)

  • Disease control rate

    24 weeks

  • Tumor marker test

    24 weeks

  • Overall survival

    2 years

Study Arms (1)

Theragene arm

EXPERIMENTAL

Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy

Drug: Theragene arm

Interventions

Theragene armDRUG

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

Theragene arm

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsAdenoviridae Infections

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Jin-Hyeok Hwang, MD PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Hyeok Hwang, MD PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 4, 2021

Study Start

February 1, 2021

Primary Completion

August 1, 2022

Study Completion

February 1, 2024

Last Updated

March 17, 2021

Record last verified: 2021-01

Locations

KR(1)