Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, chemotherapy, gimatecan
Brief 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.
Interventions
DRUGGimatecan
Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks.
Patients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks.
DRUGgemcitabine
Patients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks.
Sponsors
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months. | The 2-year progression free survival of the whole group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months. | The 2-year overall survival of the whole group. |
| Objective response rate (ORR) | To evaluate objective response rate every 6 weeks after the initiation of chemotherapy, up to 24 months. | Percentage of patients with objective response assessed by best overall. |
| Duration of Response (DoR) | First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months. | The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD). |
| Disease control rate (DCR) | To evaluate disease control rate every 6 weeks after the initiation of chemotherapy, up to 24 months. | Percentage of patients with disease control as assessed by best overall. |
| Patient-reported outcome (PRO) | To evaluate every 6 weeks after the initiation of chemotherapy, up to 24 months. | Change from baseline assessed according to the quality of life questionnaire C30. |
Countries
China
Contacts
Primary ContactWANG LIWEI, MD
Outcome results
None listed