pancreatic cancer
Conditions
Interventions
Case series:Initially treated patients with locally advanced or advanced pancreatic cancer will receive gemcitabine, nab-paclitaxel, and S-1 triple therapy chemotherapeutic regimen.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. pathologically confirmed locally advanced or advanced pancreatic cancer patient, unresectable, diagnosis with comprehensive judgment based on pathology and imaging (CT or MRI); 2. no previous antitumor treatment (including chemotherapy, radiotherapy, surgery or other investigational therapy); 3. Aged 18 to 75 years old, both gender; 4. Karnofsky Performance Status (KPS) of >70 or ECOG PS score 0- 1; 5. At least one measurable tumor lesion: long diameter of leision >=10 mm and short diameter of lymph node >=15 mm by spiral CT; the largest diameter must be >=20 mm by normal CT or physical examination; 6. The results of liver and kidney function tests and blood tests within 1 week before enrollment must meet the following conditions: Neutrophils (ANC) >=1.5x10^9/L, Platelets (PLT) >=80x10^9/L, Hemoglobin (HGB) >=80g/L, Serum creatinine (Cr) =3 months; 8. Female patients should not be pregnant during the trial; serum and urine pregnancy tests of lactating female patients should be negative during screening, and not breast-feeding; both male and female patients are required to take reliable contraception during the trial; 9. Patients voluntarily participate the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known severe hypersensitivity to any ingredient of the study drugs; 2. Patients with evidence of central nervous system (CNS) metastasis; 3. Obvious coagulation disorders, active bleeding and bleeding tendency; 4. History of other malignancies within 5 years (Except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix); 5. Serious pleural effusion or ascites; 6. Serious uncontrolled medical illness, acute infection, recent history of myocardial infarction (within 3 months); 7. severe mental disorders; 8. might be pregnant, pregnant or lactating women; 9. unsuitable for enrollment in the opinion of the investigator; 10. resectable pancreatic cancer defined by NCCN guidelines (2019 NCCN V 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicities(DLT);maximum tolerated dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;ORR;quality of life; | — |
Countries
China
Contacts
Public ContactDan Cao
West China Hospital, Sichuan University
Outcome results
None listed