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

Phase 1

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: Oncolytic virus VRT106; Drug: Chemotherapy

• Registration Number: NCT06866977
• Lead Sponsor: Xiangya Hospital of Central South University

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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-03-12
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VRT106 combination with chemotherapy	Oncolytic virus VRT106	VRT106 combination with chemotherapy
VRT106 combination with chemotherapy	Chemotherapy	VRT106 combination with chemotherapy

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	About 3 years	Incidence rate of TRAE

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	About 3 years	Overall survival rates at 12, 18, and 24 months

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China