Pancreatc cancer Pancreatic cancer
Conditions
Interventions
AHCC therapy Oral intake of AHCC (study food) will be started concurrently with the start of the first-line treatment. Oral intake of AHCC 1 g will be performed three times daily (3 g/day). Subjects w
leucovorin 200 mg/m2, day 1
and fluorouracil 2,400 mg mg/m2, 46-hour continuous infusion, 14-day cycles)
For patients homozygous for UGT1A1*6 or UGT1A1*28, or patients heterozygous for UGT1A1*6 and UGT1A1*28, treatment will be s
Sponsors
Satoi Sohei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate (1y-OS) after study enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival from study enrollment (1st OS) and progression-free survival from study enrollment (1st PFS), overall survival from the start of second-line treatment (2nd OS) and progression-free survival from the start of second-line treatment (2nd PFS), stratified analysis by UR-M or UR-LA, rate of transition to second-line treatment, dose intensity of first-line and second-line treatments, response rate and tumor marker reduction rate during first-line and second-line treatments, growth modulation index (GMI), prognostic factors in all subjects and those receiving second-line treatment, safety (adverse events) of first-line and second-line treatments, nutrition scores (neutrophil to lymphocyte ratio, prognostic nutrition index, and modified Glasgow prognostic score) before and after first-line treatment and after second-line treatment, AHCC compliance rate, rate of conversion surgery and incidence of complications | — |
Countries
Japan, noe
Contacts
Public ContactDaisuke Hashimoto
Kansai Medical University Hospital
Outcome results
None listed