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Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer

NCT02894944 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-09-12

No results posted yet for this study

Summary

Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival probability of less than 5% when all stages are combined. At present, only approximately 10%-20% of patients are considered candidates for curative resection. The majority of patients (50%-60%) are present with metastatic disease, and substantial number of patients (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.

Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic cancer in phase I study. From the experience of prostatic cancer, the safety of combination with standard chemotherapy with Theragene treatment is assessed in this study.

Conditions

Interventions

BIOLOGICAL

Theragene®,Ad5-yCD/mutTKSR39rep-ADP

Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy

Sponsors & Collaborators

  • NewGenPharm Inc.

    collaborator UNKNOWN

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-11-30
Completion
2019-04-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02894944 on ClinicalTrials.gov