Irinotecan Liposome in Combination With Capecitabine

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, and they will be treated with a regimen of liposomal irinotecan combined with capecitabine. The main research unit is the Shenzhen Hospital of the Chinese Academy of Medical Sciences Cancer Hospital. The study includes a screening period (within 28 days), a treatment period (an estimated 6 cycles, until disease progression or intolerable toxicity occurs), and a follow-up period (12 months for safety follow-up and progression-free survival (PFS) follow-up). Participants sign an informed consent form and undergo baseline examinations during the screening period. Patients who meet the inclusion and exclusion criteria enter the treatment period, and all participants complete the relevant examinations stipulated by the protocol during the treatment process to observe safety, tolerability, and efficacy. The same participant will only receive one dosing plan during the study period. After the end of the treatment period, the follow-up period begins

Inclusion criteria

• 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.

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Exclusion criteria

• 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; -