A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Safety and tolerability
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 at 18-75 years of age, inclusive, at the Screening Visit.
- •Have a clinical diagnosis of pancreatic cancer.
- •An Eastern Cooperative Oncology Group (ECOG) score of 0 or
- •Expected survival time of≥6 months.
- •No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.
Exclusion Criteria
- •Prior treatment with other oncolytic virus or systemic therapy for pancreatic cancer.
- •Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •Immunocompromised patients.
- •Known alcohol or drug dependency.
- •Women who are pregnant or breastfeeding.
Arms & Interventions
VRT106 combination with chemotherapy
VRT106 combination with chemotherapy
Intervention: Oncolytic virus VRT106 (Drug)
VRT106 combination with chemotherapy
VRT106 combination with chemotherapy
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: About 3 years
Incidence rate of TRAE（Treatment-Related Adverse Event）
Secondary Outcomes
- Disease-free survival rate(About 2 years)