Pancreatic cancer
Conditions
Interventions
Gemcitabine + NabPTx: Gemcitabine 1000mg / m2 and NabPTx 125mg / m2 are intravenously infused on the same day, and the treatment is given once a week for 3 consecutive weeks, and the drug is withdraw
Sponsors
The Jikei University school of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with pancreatic cancer confirmed by histology or cytology 2) Patients with locally advanced pancreatic cancer without distant metastases and considered difficult to resect curatively. 3) No prior treatment history (surgical excision, chemotherapy, radiation, etc.) 4) Age at registration is 20 years old or older and under 80 years old 5) Performance status (ECOG) is 0, 1 6) Expected to survive for 3 months or more from the start of treatment 7) The functions of major organs (bone marrow, liver, kidney, lung, etc.) are maintained. 8) Sufficient urine volume is secured (approximate: 1200 ml / day or more) 9) Cases that can be taken orally 10) Written consent of the person has been obtained
Exclusion criteria
Exclusion criteria: 1) Exclude non-curative factors found during radical resection 2) Have overt pulmonary fibrosis or interstitial pneumonia 3) Concomitant with active infectious diseases (HB, HCV, HIV infection, etc.) 4) Have uncontrollable diabetes, heart failure, angina, arrhythmia and myocardial infarction within 6 months of onset 5) Have watery diarrhea 6) Cases using flucytosine and phenytoin 7) Pregnant, lactating and likely or willing to become pregnant 8) Have a serious drug allergy 9) Have active double cancer (not applicable to cases 5 years after complete cure) 10) Have other serious complications 11) Have severe neuropsychiatric symptoms, renal impairment, hearing impairment 12) Chickenpox patients 13) Previous treatment history (surgical excision, chemotherapy, radiation, etc.) for this disease 14) In addition, the doctor in charge judged that it was inappropriate to carry out this study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I; Setting the optimal radiation dose Phase II; Conversion ratio | — |
Countries
Japan
Contacts
Public ContactTadashi Uwagawa
The Jikei University school of medicine Department of Surgery
Outcome results
None listed