The main goal of this clinical trial is to preliminary evaluate the efficacy of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced pancreatic cancer.And the secondary purpose is to evaluate the safety of hV01.
Signing an informed consent form.
Men or women aged 18 to 75 years.
Histologically and/or cytologically confirmed advanced malignant advanced pancreatic tumors refractory or failed to respond to standard therapy (including disease progression and/or intolerable toxicities).
At least one measurable lesion according to RECIST v1.1 criteria, which can be injected intratumorally either directly or with the assistance of Endoscopic ultrasound. The baseline longest diameter (shortest diameter for lymph node lesions) of the lesion targeted for injection should be more than 1.5 cm, and the lesion also meets the requirements of the relevant dosing volume.
Acute toxic effects from prior treatments not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v5.0) grade 1 or below, except for toxicities deemed safe by the investigator, such as alopecia.
Patients with clinical symptoms of central nervous system (CNS) metastasis or meningeal metastasis, or other evidence indicating that CNS or meningeal metastases are not controlled.
Known or suspected active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and Hashimoto's thyroiditis).
Any uncontrolled active infection requiring systemic anti-infective therapy (graded 2 or higher according to CTCAE v5.0), including but not limited to active tuberculosis, sepsis, bacteremia, fungemia, and viremia.
Single group
Recombinant human IL-21-expressing oncolytic vaccinia virus injection
Biological/VaccinehV01 is a recombinant vaccinia virus with deletions of the viral thymidine kinase (TK) and viral growth factor (VGF) genes and insertion of the human IL-21 gene.
Anti-tumor activity of hV01: overall response rate (ORR).
To evaluate the overall response rate (ORR) as a measurement of tumor response and disease progression.
Anti-tumor activity of hV01: disease control rate (DCR).
To evaluate the disease control rate (DCR) as a measurement of tumor response and disease progression.
Anti-tumor activity of hV01: duration of response (DOR).
To evaluate the duration of response (DOR) as a measurement of tumor response and disease progression.
Anti-tumor activity of hV01: progression-free survival (PFS).
To evaluate the progression-free survival (PFS) as a measurement of tumor response and disease progression.
Preliminary efficacy of hV01: overall survival (OS).
To evaluate the overall survival (OS) as a measurement of preliminary efficacy.
To assess the adverse events (AEs) and tolerability of hV01.
To assess the frequency, severity, and nature of adverse events (AEs) of hV01 administered by multiple intratumoral injections by a predetermined dose levels of 8x10\^8 PFU. This will be determined by abnormalities or changes in vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, 12-lead electrocardiogram, and laboratory test results.
morphological assessment of tumor cells
To compare the morphological characteristics of tumor cells before and after administration
To assess immune cells in the peripheral blood
To assess the levels of lymphocytes (CD3+ cells, CD3+CD4+ cells, CD3+CD8+ cells, CD3+CD4+/CD3+CD8+, CD3-CD16+CD56+ cells, CD3-CD19+ cells) in the peripheral blood.
To assess the expression levels of TILs and protein markers in tumor tissue.
To assess the expression levels of infiltrating lymphocytes (TILs) and protein markers such as PD-L1, HER2, CTLA-4 in tumor tissue before and after hV01 treatment.
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