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

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

Satoi Sohei

Kansai Medical University Hospital

2-5-1 Shin-machi, Hirakata-city, Osaka

satoi@hirakata.kmu.ac.jp

Hashimoto Daisuke

Kansai Medical University Hospital

2-5-1 Shin-machi, Hirakata-city, Osaka

+81-72-804-0101

daisukeh007@gmail.com

Recruiting

June. 25, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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
7. Be aged 20 years or older with sufficient judgement

1. Unresectable pancreatic cancer (UP-M) due to distant metastasis (eg, distant lymph nodes, liver, peritoneal dissemination, lung, pleural dissemination, brain, and bone) in General Rules for the Study of Pancreatic Cancer (the 7th Edition)
2. Local advanced unresectable pancreatic cancer (UP-LA) in General Rules for the Study of Pancreatic Cancer (the 7th Edition)
3. Already treated for pancreatic cancer before registration with such as chemotherapy, radiation, or immune therapy
4. Patients who undergo surgery without preoperative chemotherapy (up-front surgery)
5. Serious drug allergy to S-1, gemcitabine, nab-paclitaxel, paclitaxel, oxaliplatin, irinotecan, leucovorin, or fluorouracil
6. Active infectious disease (eg, pyrexia of 38 degrees of body temperature or higher)
7. Had other serious complications (eg, heart failure, kidney failure, pulmonary failure, or liver failure, uncontrollable diabetes)
8. Gastrointestinal bleeding which needs repeated blood transfusion
9. Inadequately controlled watery diarrhea
10. Complicating psychiatric disorder or psychological symptoms
11. Active multiple primary cancers
12. Pregnant, breastfeeding, childbearing potential, or willing to bear children
13. Receiving flucytosine, phenytoin, or warfarin potassium
14. Unable to provide written informed consent

Both

Pancreatic cancer

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.

Pancreatic cancer

2-year disease-free survival rate

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

+81-73-441-0896

May. 21, 2020

No

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