Pancreatic Cancer
Conditions
Keywords
Advanced pancreatic cancer
Brief summary
This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.
Detailed description
This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer. The study is planned to enroll 10 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
Sponsors
Guangzhou Virotech Pharmaceutical Co., Ltd.
Xiangya Hospital of Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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≥18 years of age, inclusive, at the Screening Visit. * Have unresectable pancreatic cancer as determined by imaging or surgical exploration and locally advanced or metastatic pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) as confirmed by histology or cytology. * No prior systemic therapy for unresectable locally advanced and metastatic pancreatic cancer. * Have at least one measurable lesion according to RECIST v1.1 criteria. * An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. * Expected survival time of≥3 months. * No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.
Exclusion criteria
* Have suffered from other malignant tumors in the past 5 years, except for cured basal cell skin cancer, non-melanoma skin cancer, and cervical cancer in situ. * Previous treatment with other oncolytic viruses. * Immunocompromised patients. * Known alcohol or drug dependency. * Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | About 3 years | Incidence rate of TRAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | About 3 years | Overall survival rates at 12, 18, and 24 months |
Countries
China
Contacts
Primary ContactXuejun Gong
Outcome results
None listed