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A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination with Chemotherapy for Resectable Pancreatic Cancer


2024-12-12


2026-09-30


2026-11-30


18

Study Overview

A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination with Chemotherapy for Resectable Pancreatic Cancer

This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.

This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer. The study is planned to enroll 18 subjects. The entire study consists of a screening period of up to 28 days, treatment period, and a follow-up period (safety follow-up 28 days after the final study dose and survival follow-up once every 3 months).

  • Pancreatic Cancer
  • DRUG: Oncolytic virus VRT106
  • DRUG: Chemotherapy
  • VRT106-C05

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-01-02  

N/A  

2025-01-02  

2025-01-02  

N/A  

2025-01-03  

2025-01-03  

N/A  

2024-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: VRT106 combination with chemotherapy

VRT106 combination with chemotherapy

DRUG: Oncolytic virus VRT106

  • VRT106, IV

DRUG: Chemotherapy

  • 21 days/cycle, administered up to 6 cycles
Primary Outcome MeasuresMeasure DescriptionTime Frame
Safety and tolerabilityIncidence rate of TRAEAbout 3 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease-free survival rateDisease-free survival rates at 6, 12, 18, and 24 monthsAbout 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chen RF Prof.

Phone Number: 020-83525210

Email: chenrf63@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures. 2. Males and females at 18-75 years of age, inclusive, at the Screening Visit. 3. Have a clinical diagnosis of pancreatic cancer. 4. An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 5. Expected survival time of≥6 months. 6. No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.
    Exclusion Criteria:
    1. Prior treatment with other oncolytic virus or systemic therapy for pancreatic cancer. 2. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation. 3. Immunocompromised patients. 4. Known alcohol or drug dependency. 5. Women who are pregnant or breastfeeding.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Guangzhou Virotech Pharmaceutical Co., Ltd.

  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available