Pancreatic Cancer
Conditions
Keywords
Resectable pancreatic cancer
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).
Interventions
VRT106, IV
DRUGChemotherapy
21 days/cycle, administered up to 6 cycles
Sponsors
Guangzhou Virotech Pharmaceutical Co., Ltd.
Guangdong Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | About 3 years | Incidence rate of TRAE（Treatment-Related Adverse Event） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival rate | About 2 years | Disease-free survival rates at 6, 12, 18, and 24 months |
Countries
China
Contacts
Primary ContactChen RF Prof.
Outcome results
None listed