Low-dose cyclophosphamide maintenance after neoadjuvant systemic chemotherapy and surgery to eradicate microscopic residual disease in PDAC

Ki vehet részt

• Written informed consent
• Adequate liver function: ALT and AST < 3 ULN; Serum total bilirubin ≤ 1.5 ULN
• Patients of any gender, race and ethnicity aged ≥18 years
• Pathological diagnosis of PDAC
• Previous radical (R0 or R1) surgical resection
• NAT with PAXG regimen (4-6 months)
• Patient’s willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives
• ECOG performance status of 2 or less
• Adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥ 100000/mm3, Hb ≥10 g/dl)
• Adequate kidney function (serum creatinine < 1.5 mg/dL)

Ki nem vehet részt

• Concurrent treatment with other experimental drugs
• Prior (within 1 year) or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin
• Subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
• Any condition that confounds the ability to interpret data from the study
• Any familiar, sociologic or geographic conditions that can potentially interfere with the adhesion to the protocol or to the follow-up
• Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine
• Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell carcinoma, cystadenocarcinoma and other periampullary malignancies
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
• Evidence of disease at any site
• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
• Pregnancy or lactation; males or female of childbearing potential not employing adequate contraceptive methods cannot be included
• Lactose intolerance: only for site that are not able to prepare a galenic formulation that can be used in substitution to commercial cyclophosphamide
• Tumor marker increase