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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Oncolytic virus VRT106; Drug: Chemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06758544

VRT106-C05

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

VRT106 combination with chemotherapy

Experimental group

Description:

VRT106 combination with chemotherapy

Treatment:

Drug: Chemotherapy

Drug: Oncolytic virus VRT106