Advanced pancreatic cancer confirmed by histopathology or cytology (including locally advanced and metastatic pancreatic cancer)
Conditions
Interventions
Advanced Pancreatic Cancer Observation Group:None
Sponsors
Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Patients with advanced pancreatic cancer (including locally advanced and metastatic pancreatic cancer) confirmed by histopathology or cytology; 3. According to the RECIST 1.1 standard, there is at least one tumor lesion that can be evaluated by imaging measurement; 4.ECOG score: 0 to 2; 5. Expected survival time >=3 months; 6. Bone marrow function: Neutrophils (ANC) >=1.5×10^9/L, platelets (PLT) >=100×10^9/L, hemoglobin (Hb) >=90g/L, white blood cells (WBC) >=3.0×10^9/L; 7. Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =60 ml/min (calculated based on Cockroft-Gault); 9. Be able to understand the situation of this study, and the patient and/or legal representative voluntarily agree to participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously received irinotecan liposome treatment; 2. Have participated in other drug clinical trials within the past four weeks; 3. Subjects who, based on the researcher's judgment, have the opportunity for surgery or are potentially eligible for surgical treatment (subjects who voluntarily give up surgical treatment may be enrolled after the researcher's assessment and approval); 4. Subjects with moderate ascites requiring drainage (except those with a small amount of ascites shown on imaging but no symptoms); 5. Symptomatic central nervous system metastases and/or cancerous meningitis are known to exist; 6. History of other primary malignant tumors, except for the following: 1) Malignant tumors that have achieved complete remission for at least 2 years before enrollment and do not require other treatments during the study period; 2) Non-melanoma skin cancer or malignant freckle-like nevus that has been adequately treated and has no evidence of disease recurrence; 3) Carcinoma in situ that has received adequate treatment and has no evidence of disease recurrence; 7. Patients with autoimmune diseases or immune deficiencies who are treated with immunosuppressive drugs. 8. The patient has a tendency to bleed. 9. Pregnant and lactating women. Women of childbearing age must have a negative pregnancy test within 7 days before enrollment. 10. Drug abuse, clinical or psychological or social factors that affect informed consent or the implementation of research. 11. People who may be allergic to irinotecan liposomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Primary endpoint: progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactJuan Du
Nanjing Drum Tower Hospital
Outcome results
None listed