A double-blind randomized phase II study of AHCC for patients with resectable / borderline resectable pancreatic cancer

INTERVENTION: AHCC group: AHCC (1.0g, 3 times per day) is given daily and also continued during preoperative and adjuvant chemotherapy, until 2‐years after operation. Placebo group: Placebo(1.0g, 3 times per day) is given daily and also continued during preoperative and adjuvant chemotherapy, until 2‐years after operation. CONDITION: Pancreatic cancer ; Pancreatic cancer PRIMARY OUTCOME: 2‐year disease‐free survival rate SECONDARY OUTCOME: completion rate and dose intensity of preoperative chemotherapy; response rate of preoperative chemotherapy; decreasing rate of tumor marker (CA 19‐9, CEA) during preoperative chemotherapy; entry rate, completion rate, and dose intensity of adjuvant chemotherapy; safety of the protocol therapy (adverse effect); 2‐year overall survival rate; nutrition score at pre‐ and post preoperative chemotherapy, and pre‐ and post adjuvant chemotherapy such as neutrophil to lymphocyte ratio, prognostic nutrition index, C‐reactive protein to albumin ratio, modified Glasgow prognostic score, platelet to lymphocyte ratio INCLUSION CRITERIA: 1.Histologically proven invasive ductal carcinoma of the pancreas (adenocarcinoma, adenosquamous carcinoma), resectable (R) or borderline resectable (BR‐A, BR‐V) in General Rules for the Study of Pancreatic Cancer (the 7th Edition) 2.Patients who undergo preoperative chemotherapy 3.Eastern Cooperative Oncology Group performance status of 0 or 1 4.Adequate bone marrow, liver, and kidney function in measurements taken within 14 days before registration (leucocyte count >= 3000 cells per mm3 and <= 12 000 cells per mm3; leucocyte count >= 2000 cells per mm3; haemoglobin concentration >= 8.0 g/dL; platelet count >= 100 000 cells per mm3; total bilirubin <= 2.0 mg/dL (3.0 mg/dL for patients with biliary stent); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations <= 150 IU/L; serum creatinine concentrations <= 1.2 mg/dL; creatinine clearance >= 50mL/min 5.Possibility of adequate oral intake 6.Provide written informed consent

Epistemonikos ID: f72020eee603ea35598d7ab2b9231248851d20ce
First added on: Aug 24, 2024