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

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.

Interventions

• Oncolytic virus VRT106 · DRUG

  VRT106, IV

• Chemotherapy · DRUG

  21 days/cycle

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• Xiangya Hospital of Central South University, Changsha, Hunan