rare fractions of hepato-pancreato-biliary cancer and neuroendocrine tumor Undifferentiated carcinoma of the pancreas, acinar cell carcinoma of the pancreas, pancreatic cancer, UGT1A1 polymorphism,combined hepatocellular-cholangiocellular carcinoma
Conditions
Interventions
Patients continue to receive treatment unless the discontinuation criteria are met.
Cohort A:
nab-paclitaxel 125mg/m2 IV over 30 minutes, followed by
Gemcitabine 1000 mg/m2 IV over 30 minutes days 1,
Gemcitabine, nab-paclitaxel, irinotecan, FOLFIRINOX, Atezolizumab, Bevacizumab
Sponsors
Ikeda Masafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort A (1) Pathologically confirmed undifferentiated carcinoma of the pancreas; (2) Unresectable disease diagnosed by contrast-enhanced CT (chest, abdomen, and pelvis) and/or MRI (abdomen and pelvis) imaging; *If the patient received adjuvant chemotherapy and the diasese recurred within 6 months after the completion, the patient is excluded from this study. (3) At least 20 years of age; (4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; (5) Measurable disease by RECIST v1.1 criteria; (6) No prior treatment for undifferentiated carcinoma of the pancreas; (7) Adequate hematologic and organ function defined by the following laboratory test results, obtained within 7 days prior to study enrollment: 1) Absolute neutrophil count (ANC) >=1,500 /mm3, 2) Hemoglobin >= 8.0 g/dL, 3) Platelet count >= 10^4/mm3, 4) Serum total bilirubin =1,500 /mm3, 2) Hemoglobin >= 8.0 g/dL, 3) Platelet count >= 10^4/mm3, 4) Serum total bilirubin =1,500 /mm3, 2) Hemoglobin >= 8.0 g/dL, 3) Platelet count >= 10 x 10^4/mm3, 4) Serum total bilirubin <= 2.0 mg/dL, 5) AST < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present), 6)
Exclusion criteria
Exclusion criteria: (1)History of malignancy (except for adequately treated carcinoma in situ, non-invasive cancer) within 2 years prior to study entry except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years; (2)Evidence of uncontrolled, active infection, requiring anti-infectious treatment, except for viral hepatitis; (3)Known central nervous system metastases (imaging required only if participants are symptomatic); (4)Symptomatic ascites or pleural effusion; (5)Significant lung disease, including interstitial lung disease, pulmonary fibrosis, or severe emphysema; (6)Active watery diarrhea; (7)Pregnant, lactating or females of childbearing age unless using highly effective contraception; (8)Male with partner of child-bearing potential unless using highly effective contraception; (9)Patients with significant psychiatric disorder; (10)History of arterial thromboembolism (e.g., myocardial infarction, unstable angina, and cerebral infarction) within 6 months prior to the initiation of study treatment; (11)Significant comorbidities, such as uncontrolled diabetes mellitus, uncontrolled hypertension, New York Heart Association (NYHA) Class III or greater cardiac disease, chronic kidney disease, or liver dysfunction; (12)Requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medication; (13)Esophageal or gastric varices with a risk of bleeding without preventive treatment; (14) History of hypersensitivity to the study drugs used in each cohort; (15)Patients whose entry in the study is considered by the investigator to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A: Objective response rate Cohort B: Objective response rate Cohort C: Objective response rate Cohort D: Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort A: Overall survival, progression-free survival, disease control rate, Duration of response, frequency of adverse events. Cohort B: Overall survival, progression-free survival, disease control rate, Duration of response, frequency of adverse events. Cohort C: Overall survival, progression-free survival, disease control rate, Duration of response, frequency of adverse events. Cohort D: Overall survival, progression-free survival, disease control rate, Duration of response, frequency of adverse events, frequency of immune-related adverse event. | — |
Contacts
Public ContactHiroshi Imaoka
National Cancer Center Hospital East
Outcome results
None listed