pancreatic cancer
Conditions
Interventions
Metastatic Pancreatic Cancer:Utidelone Injection combined with gemcitabine
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old. Karnofsky (KPS) physical status score = 70 or ECOG 0-1. 3. Metastatic pancreatic adenocarcinoma confirmed by histopathology or cytology. 4. The baseline blood routine and biochemical indexes of the subjects met the following standards: hemoglobin =90g/L; Absolute neutrophil count (ANC) =1.5×109g/L; platelets= 100×109/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times the upper limit of normal; serum total bilirubin < 1.5 times the upper limit of normal; serum creatinine < 1 times the upper limit of normal; Serum albumin = 30 g/L. 5. Heart function: a) Left ventricular ejection fraction (LVEF) =50%; b) 12-ECG shows no myocardial ischemia; c) no history of arrhythmias requiring pharmacological intervention before enrollment; 6. No concomitant severe diseases that cause survival < 5 years. 7. Agree and be able to adhere to the protocol during the study. 8. Provide written informed consent before entering the study screening.
Exclusion criteria
Exclusion criteria: 1. For those who have previously received chemotherapy, radiotherapy, targeted or immunotherapy for this pancreatic cancer. 2. Pregnant or nursing women. 3. Women of childbearing age who have a positive pregnancy test at baseline or have not undergone a pregnancy test. Menopausal women must stop menopause for at least 12 months to become pregnant. 4. Men and women who have sex (with the possibility of childbearing) who are reluctant to use contraception during the study. 5. Those with a history of other malignancies in the past five years, except for cured non-melanoma skin cancer and cervical carcinoma in situ. 6. Those with a history of uncontrolled epilepsy, central nervous system disease, or mental disorders, whose clinical severity is judged by the investigator, will hinder the signing of informed consent or affect the patient's compliance with oral medications. 7. Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more congestive heart failure, severe arrhythmias requiring drug intervention, or a history of myocardial infarction within the last 12 months. 8. Those severely allergic to castor oil or those who have used anti-microtubule drugs in the past have severe adverse reactions. 9. Known to have peripheral nerve disease =NCI CTC AE 2 level. However, the absence of deep tendon reflexes (DTR) does not need to be excluded. 10. Serious uncontrolled recurrent infection or other rampant severe concomitant diseases. 11. Moderate or severe renal impairment [creatinine clearance= 50ml/min (calculated according to Cockroft and Gault equations), or serum creatinine > upper limit of normal (ULN)]. 12. Acute or chronic active hepatitis B and hepatitis C infection, hepatitis B virus (HBV) DNA > 2000IU/ml or 104 copies/ml, hepatitis C virus (HCV) RNA > 103 copies/ml, hepatitis B surface antigen (HBsAg) and anti-HCV antibody positive at the same time. 13. Those who are allergic to any research ingredients. 14. Those who have received investigational drugs or preparations/treatments (participate in other trials) within four weeks before enrollment. 15. Patients who are unsuitable to participate in this trial for any reason judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DOR;OS; | — |
Countries
China
Contacts
Public ContactYu xian jun
Fudan University Shanghai Cancer Center
Outcome results
None listed