Liposomal Irinotecan, S-1, and Oxaliplatin in Advanced Pancreatic Adenocarcinoma (NCT04662112) | Clinical Trial Compass
CompletedPhase 1/2
Liposomal Irinotecan, S-1, and Oxaliplatin in Advanced Pancreatic Adenocarcinoma
South Korea40 participantsStarted 2021-06-15
Plain-language summary
In present study, the investigators evaluate the safety and efficacy of OIS-derived NASOX regimen (nal-IRI, S-1, oxaliplatin) in advanced pancreatic cancer. NASOX regimen contains nal-IRI, which has recently been proven effective in pancreatic cancer.
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
* Age 19 years and older
* Histologically or cytologically confirmed, measurable pancreatic adenocarcinoma
* Treatment naïve locally advanced or metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow function as defined by platelets ≥ 100 x 109/L , neutrophils ≥ 1.5 x 109/L and hemoglobin \> 9 g/dL; transfusion is allowed, provided interval is ≥ 7 days prior to screening
* Adequate renal function, with serum creatinine \< 1.5 x upper limit of normal (ULN). And calculated clearance ≥ 50 mL/min/1.73m2 for patients with serum creatinine levels above or below the institutional normal value. Actual body weight should be used for calculating creatinine clearance using the Cockcroft-Gault Equation (CreatClear = Sex x ((140 - Age) / (SerumCreat)) x (Weight / 72); for patients with body mass index (BMI) \>30 kg/m2, lean body weight should be used instead
* Adequate hepatic function with serum total bilirubin ≤ 2 x ULN (biliary drainage is allowed for biliary obstruction), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN is acceptable if liver metastases are present)
* History of any second malignancy in the last 3 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 3 years.
* Female patients must be e…