a phase ii study of gimatecan (st1481) in locally advanced or metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: 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.


Eligibility criteria:
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).

Keywords: pancreatic cancer chemotherapy gimatecan