Multicenter Phase II Study of AHCC (Functional Food) to Explore Improvement in Treatment Outcome in Patients with Unresectable Pancreatic Cancer

JRCT ID: jRCTs051210156

Registered date:20/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatc cancer
• Date of first enrollment: 10/03/2022
• Target sample size: 130
• Countries of recruitment: noe,Japan
• Study type: Interventional

Intervention(s)

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 who have completed the second-line treatment will continue oral AHCC whenever possible until the end of the observation period.
First-line treatment: GnP therapy (nab-paclitaxel 125 mg/m2, gemcitabine 1,000 mg/m2, days 1, 8, and 15, of a 28-day cycle)
Second-line treatment: liposomal irinotecan + 5-FU/LV (liposomal irinotecan 70 mg/m2, day 1; 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 started at a reduced dose level in accordance with the package inserts.

Outcome(s)

• Primary Outcome: 1-year overall survival rate (1y-OS) after study enrollment
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Satoi Sohei
• Source(s) of Monetary Support: NIHON SERVIER CO., LTD.