Status:
RECRUITING
Irinotecan Liposome in Combination With Capecitabine
Lead Sponsor:
Junjie Hang
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Pancreatic cancer is a group of malignant tumors mainly originated from pancreatic ductal epithelium and follicular cells, with high degree of malignancy, insidious onset, difficult early diagnosis, r...
Detailed Description
This study is a prospective, multicenter, single-arm phase II study. It is expected to include 20 patients with unresectable/metastatic pancreatic cancer who have relapsed after standard treatment, an...
Eligibility Criteria
Inclusion
- patients were fully aware of the study, participated voluntarily and signed the informed consent form (ICF);
- aged ≥18 years and ≤80 years;
- patients with histopathologically confirmed unresectable/metastatic pancreatic cancer;
- imaging-confirmed tumor progression after prior treatment with a standard first-line regimen;
- patients with at least one measurable target lesion according to RECIST 1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) physical status score: 0-2;
- expected survival time ≥ 3 months;
- absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L and hemoglobin ≥ 90 g/L (not transfused with blood, blood products, or corrected with granulocyte colony-stimulating factor or other hematopoietic-stimulating factor in the 14 days prior to the laboratory test);
- Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value.
- Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver metastases); total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver metastases); 10. Women of childbearing potential must have had a negative pregnancy test (serum) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 6 months after the last administration of the test drug.
- \-
Exclusion
- hypersensitivity to any of the study drugs or their components;
- concomitant serious uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe renal impairment; (e.g., progressive infections, uncontrollable hypertension, diabetes mellitus, etc.);
- cardiac function and disease consistent with one of the following conditions
- Long QTc syndrome or QTc interval \>480 ms;
- Complete left bundle branch block, degree II or degree III atrioventricular block;
- Severe, uncontrolled arrhythmia requiring pharmacologic therapy;
- New York Society of Cardiology classification ≥ grade III;
- Cardiac ejection fraction (LVEF) less than 50%;
- History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormality within 6 months prior to recruitment.
- active hepatitis B or C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA greater than 1x103 copies/mL; hepatitis C virus RNA greater than 1x103 copies/mL), except for asymptomatic chronic hepatitis B or hepatitis C carriers;
- human immunodeficiency virus (HIV) infection (HIV-positive);
- imaging confirmation of intestinal obstruction;
- previous or current concurrent other malignancies (except effectively controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment within the past five years);
- pregnant and lactating women and patients of childbearing age who do not wish to use contraception;
- patients with other malignant tumors requiring treatment;
- patients who, in the judgment of the investigator, are not suitable for participation in this study.
- history of pulmonary hemorrhage/coughing up ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to the first dose of drug;
- a predisposition to arterial embolism, severe hemorrhage (other than bleeding due to surgery), and severe bleeding within 6 months prior to first dose;
- a combination of symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression
- use of strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days prior to receiving study drug therapy
- who have used other clinical trial medications within 1 month prior to the first dose;
- pregnant or lactating female patients, subjects of childbearing age who refuse to accept contraception; -
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06578052
Start Date
August 28 2024
End Date
December 31 2027
Last Update
February 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Shenzhen, Guangdong, China, 518100