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

NCT06758544 | Recruiting Phase 1

• 1 other identifier: VRT106-C05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Resectable pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Incidence rate of TRAE（Treatment-Related Adverse Event）

  About 3 years

Secondary Outcomes (1)

• Disease-free survival rate

  About 2 years

Study Arms (1)

VRT106 combination with chemotherapy

EXPERIMENTAL

VRT106 combination with chemotherapy

Drug: Oncolytic virus VRT106; Drug: Chemotherapy

Interventions

Oncolytic virus VRT106 DRUG

VRT106, IV

VRT106 combination with chemotherapy

Chemotherapy DRUG

21 days/cycle, administered up to 6 cycles

VRT106 combination with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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 1.
• Expected survival time of≥6 months.
• No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Guangzhou Virotech Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Chen RF Prof.

CONTACT

020-83525210; chenrf63@163.com

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: January 2, 2025
• First Posted: January 3, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)