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

March 4, 2025 updated by: Xiangya Hospital of Central South University
This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

The study is planned to enroll 10 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).

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

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

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital of Central South University
        • Contact:
          • Xiangya Hospital of Central South University
          • Phone Number: 0731-84327919

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Males and females≥18 years of age, inclusive, at the Screening Visit.
  • Have unresectable pancreatic cancer as determined by imaging or surgical exploration and locally advanced or metastatic pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) as confirmed by histology or cytology.
  • No prior systemic therapy for unresectable locally advanced and metastatic pancreatic cancer.
  • Have at least one measurable lesion according to RECIST v1.1 criteria.
  • An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  • Expected survival time of≥3 months.
  • No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.

Exclusion Criteria:

  • Have suffered from other malignant tumors in the past 5 years, except for cured basal cell skin cancer, non-melanoma skin cancer, and cervical cancer in situ.
  • Previous treatment with other oncolytic viruses.
  • Immunocompromised patients.
  • Known alcohol or drug dependency.
  • Women who are pregnant or breastfeeding.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VRT106 combination with chemotherapy
Drug: Oncolytic virus VRT106
VRT106, IV
Other Names:
  • VRT106
Drug: Chemotherapy
21 days/cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: About 3 years
Incidence rate of TRAE
About 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate
Time Frame: About 3 years
Overall survival rates at 12, 18, and 24 months
About 3 years

Collaborators and Investigators

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

Sponsor

Xiangya Hospital of Central South University

Collaborators

Guangzhou Virotech Pharmaceutical Co., Ltd.

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 Major Dates

Study Start (Estimated)

March 12, 2025

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRT106-C04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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