Metastatic pancreatic cancer
Conditions
Interventions
Case series:nab-paclitaxe 200mg/d, d1, 8
until disease progression, death or unacceptable toxicity
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has good compliance, understands the research process of the study and signs a written informed consent form.; 2. >=65 years of age, or ECOG PS= 2, or weight loss >=10% within one month prior to enrollment; 3. The patient's body surface area >=1.4m2; 4. Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma; 5. Patients with distant metastases; 6. If the patient has received neoadjuvant/adjuvant chemotherapy, the chemotherapy regimen should be free of paclitaxel. The last dose is more than 6 months from the time of enrollment, and there is no delayed toxicity; 7. Patients have at least one evaluable lesion according to the RECIST 1.1; 8. The expected lifetime must be greater than 12 weeks; 9. Bone marrow function criteria: hemoglobin (HGB)>=90g/L; absolute neutrophil count (ANC)>=1.5x10^9/L; platelets (PLT)>=100x10^9/L; 10. Liver function criteria: ALT, AST<=2.5 ULN, if there is liver metastasis, ALT, AST<=5 ULN; serum total bilirubin< 1.5 ULN; 11. Renal function criteria: serum creatinine is within normal range; 12. Patients without biliary obstruction who require biliary stent implantation must be completed at least 21 days prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. It is known to be allergic to paclitaxel or human serum albumin; 2. Patients who have had other malignant tumors in the past 5 years (except for cured carcinoma in situ or basal cell carcinoma of the skin); 3. Patient with >=grade II peripheral neuropathy currently or previously; 4. Patient with brain metastasis or weight-bearing bone transfer; 5. Patient with interstitial pneumonia or pulmonary fibrosis; 6. Patient with severe pleural effusion or ascites; 7. Patient with watery diarrhea; 8. Patient with complete or incomplete intestinal obstruction; 9. Patient with serious concurrent diseases that may affect the study administration, or the results evaluation: such as HIV-positive, active chronic HBV/HCV, diabetesand poorly controlled by hypoglycemic drugs, clinically serious (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease, or a history of mental disorders; 10. Participated in other clinical trails within 4 weeks prior to enrollment; 11. Investigators believe that patient who is not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-months OS;OS;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS; | — |
Countries
China
Contacts
Public ContactShen Lin
Department of Gastrointestinal Oncology, Beijing Cancer Hospital
Outcome results
None listed