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

Phase 2

• Conditions: Pancreas Cancer
• Interventions: Drug: Theragene arm

• Registration Number: NCT04739046
• Lead Sponsor: Seoul National University Bundang Hospital

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

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-02-01
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17
• Primary Completion: 2022-08-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Disease control rate	24 weeks	the proportion of patients with advanced or metastatic cancer who have achieved complete response, partial response or stable disease

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of