A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic Cancer
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 pancreatic-cancer
Started Mar 2025
Shorter than P25 for phase_1 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 10, 2025
February 1, 2025
8 months
March 4, 2025
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
Incidence rate of TRAE
About 3 years
Secondary Outcomes (1)
Overall survival rate
About 3 years
Study Arms (1)
VRT106 combination with chemotherapy
EXPERIMENTALVRT106 combination with chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangya Hospital of Central South University
Changsha, Hunan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2025
First Posted
March 10, 2025
Study Start
March 12, 2025
Primary Completion
October 31, 2025
Study Completion
December 31, 2025
Last Updated
March 10, 2025
Record last verified: 2025-02