A Single-arm, Open-label Clinical Study To Evaluate The Efficacy And Safety Of VRT106 In Combination With Chemotherapy For Advanced Pancreatic Cancer

Study Overview

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

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).

Pancreatic Cancer

DRUG: Oncolytic virus VRT106
DRUG: Chemotherapy

VRT106-C04

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
First Submitted 2025-03-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-04
First Submitted that Met QC Criteria 2025-03-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-10
First Posted (ACTUAL) 2025-03-10	Results First Posted N/A	Last Verified 2025-02

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/Arm	Intervention/Treatment
EXPERIMENTAL: VRT106 combination with chemotherapy VRT106 combination with chemotherapy	DRUG: Oncolytic virus VRT106 VRT106, IV DRUG: Chemotherapy 21 days/cycle

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: VRT106 combination with chemotherapy

VRT106 combination with chemotherapy

DRUG: Oncolytic virus VRT106

VRT106, IV

DRUG: Chemotherapy

21 days/cycle

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

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival rate	Overall survival rates at 12, 18, and 24 months	About 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: Xuejun Gong

Phone Number: 0731-84327919

Email: peigong158@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:

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.

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.

Collaborators and Investigators

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

Guangzhou Virotech Pharmaceutical Co., Ltd.

Investigators

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

Learn

Resources

PatientS

Caregivers

Clinical Trial Record