pancreatic cancer
Conditions
Interventions
Control Group:Regiments
Sponsors
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Pancreatic cancer diagnosed by histopathology or cytology should be a malignant tumor originating from the ductal epithelium of the pancreas, excluding pancreatic endocrine tumors; 2. Locally advanced or metastatic pancreatic cancer that is not suitable for radical radiotherapy or surgical treatment; 3. Have previously received gemcitabine or 5-Fu drugs (single drug or combined with other drugs; conventional dose, non-radioactive sensitization dose) failure of first-line treatment (disease progression during treatment or within 6 months after the end of treatment, there is clear imaging evidence; toxicity is intolerable); 4. For those who have used chemotherapy drugs, molecular targeted drugs or radical radiotherapy in the past, they need to stop the drug for more than 3 weeks and recovery from previous toxicity = 18 years, no gender limit; 7. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0~1 (Appendix 2); 8. The expected survival time exceeds 3 months; 9. The test results of each organ function of the subject must meet the following conditions: 1) Hematopoietic function (no blood components, cell growth factors, whitening drugs, platelet-increasing drugs, drugs for correcting anemia, etc. have been used in the 14 days before screening): a. Hemoglobin >= 90g/L; b. The absolute value of neutrophils >= 1.5 x 10^9/L; c. The platelet count >= 85 x 10^9/L; 2) Kidney: blood creatinine = 60ml/min (Cockcroft-Gault formula, Appendix 3), And urine protein 2+ or 1.0 g/L. For patients with urine protein >= 2+ or >= 1.0 g/L at baseline, a 24-hour urine protein quantitative test should be performed and must be = 1.5 x UNL (for obstructive jaundice drainage, it can be = 30 g/L; 10. The subject has no history of allergy to camptothecin drugs; 11. Can be used orally; 12. Women of childbearing age should undergo a pregnancy test within 7 days before the treatment, and the result is negative before they can be admitted; Male and female subjects and their sexual partners agree to use reliable contraceptive measures during the study treatment period and within 1 month after the end of the study treatment period [such as intrauterine birth control (IUD) or condoms]; 13. Volunteer to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) The subject had received camptothecin-containing drug treatment or any topoisomerase-containing I inhibitor regimen drug treatment within 6 months before enrollment; (2) Patients who used gemcitabine and fluorouracil in the first-line treatment within 6 months before enrollment; (3) Participated in other drug clinical trials within 4 weeks before enrollment; (4) Known brain metastasis or pia materosis, patients with suspected central nervous system metastasis need to have a head examination; (5) Clinically obvious abnormalities in the digestive tract may affect the intake, transport or absorption of drugs, such as inability to swallow,chronic diarrhea, intestinal obstruction, intestinal bleeding within six months (3 consecutive times of negative stool occult blood test can be excluded), total gastrectomy, etc.; (6) Serous effusions with clinical symptoms (such as pleural effusion, abdominal effusion, pericardial effusion, etc.) should be protected by internal medicine after 2 weeks of conservative treatment (excluding drainage), the effusion is still increasing; (7) Hypertension not controlled by drugs (>=160/100mmHg); angina pectoris and unstable angina pectoris that started within the last 3 months, myocardial infarction or cardiac insufficiency occurred within 1 year before enrollment (>= New York Heart Association NYHA Class II, Appendix 4); (8) Active infections requiring systemic treatment, or fever of unknown origin (except for tumorous fever) before the first administration; (9) Hepatitis B surface antigen is positive and peripheral blood HBV-DNA titer test is >= 1.0 x 10^3 copies/mL; hepatitis C virus antibody is positive and peripheral blood HCV RNA is positive; (10) Those who have active tuberculosis, or have a history of tuberculosis infection but have not been controlled after treatment; (11) Known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome Syndrome (AIDS); (12) Have a history of other malignant tumors other than pancreatic cancer (cured cervical carcinoma in situ or skin basal cells (Except for cancer and other malignant tumors that have been cured for 5 years); (13) Women during pregnancy or lactation; (14) Have a clear history of mental disorders (including epilepsy or dementia); (15) Other situations that the researcher considers inappropriate to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DoR;Safety; | — |
Countries
China
Contacts
Public ContactLiwei Wang
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Outcome results
None listed