Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery. We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.
This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
one tablet of V3-P given once daily for 2 months
Immunitor LLC
Ulaanbaatar, Mongolia
RECRUITINGNational Cancer Center
Ulaanbaatar, Mongolia
ENROLLING_BY_INVITATIONEffect of V3-P on tumor burden
Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-P in an open label trial in patients with inoperable pancreatic cancer.
Time frame: 3 months
Safety of V3-P
Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE.
Time frame: 3 months
Effect of V3-P on sugar and bilirubin levels
Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function
Time frame: 3 months
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