Pancreatic cancer
Conditions
Interventions
Patients with locally advanced or liver metastasis of pancreatic cancer:None
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old, both male and female; 2. Histologically or cytologically confirmed pancreatic cancer (originating from pancreatic ductal epithelium), with locally advanced disease or liver metastases as documented in clinical records. 3. Patients with advanced pancreatic cancer who received prior fluorouracil, oxaliplatin, and irinotecan (FOLFIRINOX); or gemcitabine and/or nanoparticle albumin-bound paclitaxel-based chemotherapy regimens, i.e., after progression on standard first-line therapy. 4. Based on RECIST 1.1 criteria, patients must have at least one measurable lesion. 5.? ECOG performance status of 0 or 1; 6. Life expectancy of at least 12 weeks; 7. Organ function must meet the following requirements (with no use of any blood products, hematopoietic growth factors, granulocyte colony-stimulating factors, thrombopoietic agents, erythropoiesis-stimulating agents, etc., within 14 days prior to the first dose of study drug); 8. Female subjects of childbearing potential must provide documentation of a negative pregnancy test (serum or urine) within 7 days before enrollment and must commit to using a highly effective method of contraception consistently throughout the observation period and for 8 weeks following the final administration of the investigational product. Male subjects must either be surgically sterile or provide consent to use a highly effective method of contraception consistently during the observation period and for 12 weeks after the final dose of the investigational product; 9. Subjects will voluntarily participate in the study and sign the informed consent form prior to any study-related procedures;
Exclusion criteria
Exclusion criteria: 1.? Patients with pancreatic cancers originating from non-ductal epithelium, including:? ?Pancreatic neuroendocrine carcinoma (NEC)? ?Pancreatic acinar cell carcinoma? ?Pancreatoblastoma? ?Solid-pseudopapillary neoplasm (SPN); 2.? Patients with known central nervous system (CNS) metastases; 3. Severe gastrointestinal impairment (e.g., hemorrhage, inflammation, obstruction, or diarrhea of Grade >1); 4.? Presence of grade 3 or 4 peripheral neuropathy (PN); 5.? Presence of refractory pleural effusion, pericardial effusion, or ascites requiring drainage; 6.? Uncontrolled systemic infection (viral, bacterial, and fungal); 7. History of hypersensitivity to liposomal irinotecan, other liposomal products, oxaliplatin, 5-fluorouracil (5-FU), calcium folinate, or any component thereof; 8. Receipt of ?any investigational agent? within 4 weeks prior to the ?first dose of study drug?; Undergoing ?major surgery? within 4 weeks prior to the first dose of study drug; Concurrent enrollment in ?another clinical study?, unless it is an ?observational (non-interventional) study? or the ?follow-up phase of an interventional study; 9. Subjects exhibiting ?clinically significant cardiovascular compromise? meeting ANY of the following: ?Decompensated heart failure? (>= NYHA Class II) Active ?unstable coronary syndrome? History of ?acute myocardial infarction? = 2000 IU/mL or 104 copies/mL) or hepatitis C (positive for hepatitis C antibody and/or HCV RNA above the lower limit of quantification); 11. Prior diagnosis of ?malignancies other than? those meeting ?low-risk criteria? (defined as >90% 5-year DSS*) within 5 years before enrollment, ?excluding?: ?Curatively resected? non-melanoma skin cancers ?Stage 0 cervical cancer? with confirmed clear margins Ductal carcinoma in situ (DCIS) of breast ?with complete excision; 12. Pregnant or lactating women; 13. Subjects deemed by the investigator to have ?other factors potentially necessitating premature discontinuation?, including but not limited to: Concurrent ?severe medical/psychiatric conditions? requiring active intervention ?Social/family circumstances? that may compromise subject safety or data integrity; 14. Other conditions deemed by the investigator to be inappropriate for participation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Overall survival (OS);Progression free survival (PFS); | — |
Countries
China
Contacts
Public ContactYin Tao
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed