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NCT Number: NCT06758544

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 1.
  • 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.

Treatment and study plan

Oncolytic virus VRT106

Drug

VRT106, IV

Chemotherapy

Drug

21 days/cycle, administered up to 6 cycles

Primary outcomes

  1. Safety and tolerability

    Time frame: About 3 years

    Incidence rate of TRAE(Treatment-Related Adverse Event)

Secondary outcomes

  1. Disease-free survival rate

    Time frame: About 2 years

    Disease-free survival rates at 6, 12, 18, and 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Chen RF Prof.

CONTACT

[email protected]

020-83525210

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • Guangzhou Virotech Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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