A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer
A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer
This phase II clinical trial studies the safety and effect of as second-line treatmen in
 local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.
Key inclusion Criteria:

 1. Histologically or cytologically confirmed pancreatic cancer originating from
 pancreatic ductal epithelium, excluding pancreatic endocrine tumor;

 2. Locally advanced or metastatic pancreatic cancer in no condition for radical
 radiotherapy or operation;

 3. Failed in first-line gemcitabine or fluorouracil drugs chemotherapy (Recurrence within
 6 months after treatment, progression or toxicity intolerance during treatment);

 4. Chemotherapy, targeted therapy or radical radiotherapy should be stopped 3 weeks ago,
 immunotherapy should be stopped 4 weeks ago, and previous toxicity recovered (CTCAE ≤
 level 1);

 5. Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors
 (RECIST) v1.1;

 6. No younger than 18 years old of either gender;

 7. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;

 8. Estimated life expectancy >3 months;

 9. The function of important organs meets the following requirements:

 1. absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 85×109/L, hemoglobin ≥
 90g/L;

 2. serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min, U-pro < 2+ or
 1.0g/L; if U-pro ≥2+ or 1.0g/L, 24 hours U-pro ≤ 1.0g/L can be included;

 3. total bilirubin ≤ 1.5×ULN, obstructive jaundice with biliary drainage: total
 bilirubin ≤ 2.0×ULN; alanine transaminase and aspartate aminotransferase ≤
 2.5×ULN, liver metastasis ≤ 5.0×ULN; serum albumin ≥ 30g/L;

 10. Without a history of allergy or hypersensitivity to camptothecin drugs;

 11. Taking drugs orally;

 12. Serum human chorionic gonadotropin negative in premenopausal women; female patients of
 childbearing potential and male patients with female partners of childbearing
 potential must be willing to avoid pregnancy;

 13. Ability to understand the study and sign informed consent.

 Key exclusion Criteria:

 1. Patients who have been previously treated with camptothecin drugs or topoisomerase I
 inhibitor within 6 months before enrollment;

 2. Patients who have been previously treated with gemcitabine and fluorouracil in
 first-line treatment within 6 months before enrollment;

 3. Patients who have been previously treated with other investigational drugs within 4
 weeks before enrollment;

 4. Patients with brain or meningeal metastasis;

 5. Patients with a history of gastrointestinal disease which affects drug absorption;

 6. Patients with serous cavity effusion with clinical symptoms (such as pleural effusion,
 peritoneal effusion, pericardial effusion, etc.), which continue to increase after
 two-week conservative treatment (excluding puncture drainage);

 7. Patients with hypertension that cannot be controlled by drugs (≥ 160/100mmhg); angina
 pectoris within 3 months before enrollment or unstable angina pectoris; myocardial
 infarction within 1 year before enrollment and cardiac insufficiency (NYHA ≥ II);

 8. Patients with active infections requiring systemic treatment or pyrexia of unknown
 origin prior to initial administration (except neoplastic fever);

 9. Patients with hepatitis B surface antigen positive and peripheral blood hepatitis B
 virus DNA ≥1.0×103 copy/mL; positive of hepatitis C antibody and peripheral blood
 hepatitis C virus RNA;

 10. Patients with active pulmonary tuberculosis or uncontrolled pulmonary tuberculosis
 after anti-tuberculosis treatment;

 11. Patients with a history of immunodeficiency (including a positive HIV test result), or
 other acquired or congenital immunodeficiency diseases;

 12. Patients with a history of malignancies other than pancreatic cancer before
 enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or malignant
 tumors that have been cured for 5 years;

 13. Pregnant or lactating women;

 14. Patients with a history of mental diseases (including epilepsy or dementia).