Locally advanced pancreatic cancer or postoperative recurrent pancreatic cancer
Conditions
Interventions
Treatment group:Irinotecan Liposome +CCRT
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, male or female; 2. Histopathologically or cytopathologically confirmed diagnosis of pancreatic cancer; 3. Locally advanced pancreatic cancer or postoperative recurrent pancreatic cancer as defined by the AJCC Staging System (9th Edition); 4. ECOG score of 0-1; 5. No prior radiotherapy or any palliative chemotherapy or systemic antitumor therapy; 6. =1 measurable lesion (CT/MRI, RECIST v1.1); 7. Bone marrow function: neutrophil count (ANC) >=1.5×10?/L, platelet count (PLT) >=75×10?/L, hemoglobin (Hb) >=90 g/L; 8. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 g/dL; 9. Renal function: serum creatinine (Cr) =60 mL/min (calculated by Cockcroft-Gault formula); urine protein =50%; 10. Cardiac function: left ventricular ejection fraction >=50%; 11. Female participants must have a negative serum pregnancy test within 72 hours before receiving study treatment (if of childbearing potential) and agree to use contraception for 150 days after the last dose of study treatment, or be non-childbearing. Male partners must agree to use appropriate contraception from the first dose of study treatment until 150 days after the last dose. 12. Participants must agree not to breastfeed during the study or for 150 days after the last treatment; 13. Expected survival time greater than 3 months; 14. Acceptance of the combined treatment regimen of this study and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Tumor invasion of the gastrointestinal tract; 2. History of other malignancies within the past 5 years (except for cured and non-recurrent conditions such as carcinoma in situ or basal cell carcinoma of the skin); 3. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined as persistent signs/symptoms associated with the infection without improvement despite appropriate antibiotic, antiviral, and/or other therapy; 4. History of immunodeficiency, such as known active HIV infection (i.e., HIV1/2 antibody positive), other acquired or congenital immunodeficiency disorders, history of organ transplantation, or other immune-related diseases requiring oral hormonal therapy; 5. Uncontrolled systemic diseases, including cardiovascular conditions such as unstable angina, myocardial infarction (within 12 months), congestive heart failure, severe unstable ventricular arrhythmias, or severe pericardial diseases; uncontrolled hypertension (defined as systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg after standardized antihypertensive treatment) or history of hypertensive crises or hypertensive encephalopathy; uncontrolled diabetes (fasting blood glucose >=10 mmol/L), etc.; 6. Known allergy or intolerance to the investigational drugs or their excipients used in this study protocol. 7. Administration of Chinese herbal medicines with anti-tumor indications or drugs with immunomodulatory effects within 4 weeks prior to the first dose; 8. Current participation in another interventional clinical research study; 9. Use of strong inhibitors or inducers of CYP3A4, CYP2C8, UGT1A1, or similar enzymes; 10. Pregnant or lactating women, as well as patients of childbearing potential who refuse to adopt appropriate contraceptive measures during the trial; 11. Patients with impaired cognitive ability who are unable to answer questions, complete questionnaires, or have psychiatric disorders; 12. Any other condition deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Correlation analysis of disease progression;Disease Control Rate;Safety;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactGuo Leiming
Henan Cancer Hospital
Outcome results
None listed