Multicenter Phase II Study of AHCC (Functional Food) to Explore Improvement in Treatment Outcome in Patients with Unresectable Pancreatic Cancer - Phase II study of AHCC for unresectable pancreatic cancer

Satoi Sohei0 个研究点目标入组 130 人开始时间: 2022年1月20日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Patients with pancreatic cancer that was histologically or cytologically confirmed to be adenocarcinoma who have unresectable locally advanced (UR-LA) or unresectable metastastic (UR-M) pancreatic cancer according to the General Rules for the Study of Pancreatic Cancer (the 7th edition) at enrollment and are planning to receive initial treatment
•2. Patients with measurable disease according to the new Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1
•3. Patients who are planning to receive nab-paclitaxel + gemcitabine as first-line treatment and liposomal irinotecan + 5-FU/LV as second-line treatment
•4. Patients with an Eastern Cooperative Oncology Group performance status (PS) of 0 to 2
•5. Patients with preserved function of major organs (e.g., bone marrow, liver, kidneys, and lungs) (within 14 days before enrollment)
•6. Patients who are capable of oral intake
•7. Patients who have not received any treatment (e.g., radiotherapy, chemotherapy, and immunotherapy) for the underlying disease
•8. Patients who provided written informed consent to be a subject in the present study
•9. Adults aged 20 years or older who have sufficient ability to judge whether they participate in the study

•1. Patients with pancreatic cancer that recurred after surgery
•2. Patients who are not planning to receive chemotherapy
•3. Patients in whom gemcitabine, nab-paclitaxel or paclitaxel, oxaliplatin, liposomal-irinotecan, leucovorin, or fluorouracil is contraindicated
•4. Patients with evident infection or inflammation at study enrollment
•5. Patients with serious complications
•6. Patients with gastrointestinal fresh bleeding requiring repeated blood transfusion
•7. Patients with diarrhea
•8. Patients with psychiatric disorder that is being treated with or may require antipsychotic drugs who cannot understand explanation
•9. Patients who have double cancer at enrollment, except carcinoma in site, intramucosal carcinoma, and any cancer that is not a prognostic factor as compared with the targeted cancer
•10. Pregnant or breastfeeding women or those who are willing to become pregnant
•11. Males of childbearing potential whose partner is a female of childbearing potential and who do not intend to use contraception during and after the study
•12. Patients who are unlikely to provide effective informed consent

发起方

Satoi Sohei