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

Phase 1

Recruiting

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

• Registration Number: NCT06758544
• Lead Sponsor: Guangdong Provincial People's Hospital

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-12
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-09-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. 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.
2. Males and females at 18-75 years of age, inclusive, at the Screening Visit.
3. Have a clinical diagnosis of pancreatic cancer.
4. An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
5. Expected survival time of≥6 months.
6. No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.

Exclusion Criteria

1. Prior treatment with other oncolytic virus or systemic therapy for pancreatic cancer.
2. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
3. Immunocompromised patients.
4. Known alcohol or drug dependency.
5. 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
Disease-free survival rate	About 3 years	Disease-free survival rates at 6, 12, 18, and 24 months

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China