Pancreatic cancer
Conditions
Interventions
This study is an interventional trial in which patients with resectable pancreatic cancer receive neoadjuvant therapy consisting of gemcitabine, nab-paclitaxel, and S-1.
Gemcitabine and nab-paclitaxel
Sponsors
Uemura Kenichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with pancreatic cancer confirmed by histological examination, cytological examination, or imaging studies of the primary lesion. 2. Patients with resectable pancreatic cancer who meet the following criteria based on a multidetector row computed tomography scan performed within four weeks prior to informed consent, in accordance with the NCCN Guidelines Version 2.2025. a. No evidence of distant metastasis. b. No tumor contact with major peripancreatic arteries including the common hepatic artery, proper hepatic artery, superior mesenteric artery, or celiac artery. c. Tumor contact with the portal vein of less than 180 degrees, or no contact with the portal vein. d. Serum CA19 9 or DUPAN 2 levels exceeding the upper limit of normal at the time of diagnosis. 3. Patients with at least one measurable lesion according to RECIST version 1.1. 4. Patients who have not received prior treatment. 5. Patients with an Eastern Cooperative Oncology Group performance status of zero or one. 6. Patients with adequate organ function meeting the following criteria based on laboratory values obtained within fourteen days prior to registration. White blood cell count of twelve thousand per cubic millimeter or lower. Absolute neutrophil count of one thousand five hundred per cubic millimeter or higher. Hemoglobin level of nine point zero grams per deciliter or higher. Platelet count of one hundred thousand per cubic millimeter or higher. Total bilirubin level below two point zero milligrams per deciliter. Total bilirubin level of three point zero milligrams per deciliter or lower in patients after biliary drainage. Serum creatinine level of one point five milligrams per deciliter or lower. Aspartate aminotransferase and alanine aminotransferase levels no greater than two point five times the institutional upper limit of normal. 7. Patients who have provided written informed consent prior to enrollment.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of severe drug hypersensitivity or drug allergy. 2.Patients with a history of malignancy, except for those who have been disease-free for more than 5 years, or those with carcinoma in situ treated curatively by endoscopic resection, curatively treated cervical cancer, or basal cell carcinoma or squamous cell carcinoma of the skin treated curatively. 3.Patients with active infection. 4.Patients with peripheral sensory neuropathy of Grade 2 or higher. 5.Patients with paralytic ileus or intestinal obstruction. 6.Patients with a history of or concurrent interstitial pneumonia or pulmonary fibrosis. 7.Patients with uncontrolled ascites or pleural effusion. 8.Patients currently receiving flucytosine, phenytoin, or warfarin. 9.Patients with uncontrolled diabetes mellitus. 10.Patients with uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmia. 11.Patients with a history of or concurrent severe neurological or psychiatric disorders. 12.Patients with diarrhea, including increased stool frequency and/or watery stools. 13.Pregnant or breastfeeding women, or patients who are pregnant or intend to become pregnant. 14.Patients who are deemed inappropriate for participation in this clinical trial at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate and median overall survival from the initiation of protocol treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Recurrence-free survival from the initiation of protocol treatment. 2) Objective response rate to neoadjuvant chemotherapy, and normalization rates of tumor markers (CA19-9, CEA, and DUPAN-2) before and after surgery. 3) Histopathological response, graded according to the Evans classification based on the percentage of tumor cell disappearance. 4) Resection rate. 5) Rate of curative resection (R0 or R1) (R1: no macroscopic residual tumor; R0: no microscopic residual tumor). 6) Proportion of patients who initiated and completed adjuvant chemotherapy. 7) Dose intensity. | — |
Contacts
Public ContactKenjiro Okada
Hiroshima university Hospital
Outcome results
None listed