pancreatic cancer
Conditions
Interventions
Experimental group:Sapanisertib: 240mg, intravenous infusion, on day 1 and day 15, every 28 days.
NALIRIFOX regimen:
Irinotecan liposome injection 50 mg/m2, 5-fluorouracil (5-FU) 2400 mg/m2, leucovori
The control group:NALIRIFOX regimen:
Irinotecan liposome injection 50 mg/m2, 5-fluorouracil (5-FU) 2400 mg/m2, leucovorin (LV) 400 mg/m2, oxaliplatin 60 mg/m2, intravenous infusion, on day 1 and day 1
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical study; complete understanding of and informed consent for the study, evidenced by signing the informed consent form. 2. Age =18 years and =75 years. 3. Locally advanced pancreatic cancer confirmed histologically according to the NCCN Pancreatic Cancer Guidelines v2.2023. 4. No prior treatment received. 5. At least one measurable lesion suitable as a target lesion according to RECIST v1.1 criteria. 6. Normal function of major organs within 14 days before the first treatment (See the research plan for details). 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1. 8. For participants who are hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive, HBV DNA testing should be conducted, and participants with HBV DNA 3 months.
Exclusion criteria
Exclusion criteria: 1. Presence of metastatic pancreatic cancer. 2. Patients with active autoimmune diseases or a history of autoimmune diseases. 3. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (excluding corneal transplantation). 4. Use of immunosuppressive drugs within 14 days prior to medication, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/day of prednisone or equivalent physiological doses of other corticosteroids). 5. History of thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic events, implanted venous infusion port or catheter-related thrombosis, or superficial venous thrombosis. Exclusion criteria do not apply to stable thrombosis after routine anticoagulant treatment, and prophylactic use of low-dose low molecular weight heparin is permitted. 6. Known history of gastrointestinal perforation, gastrointestinal fistula, or reproductive tract fistula (such as bladder-vaginal fistula, urethral-vaginal fistula, bladder-cervical fistula, etc.). If perforation or fistula has been treated with diversion surgery, resection, or repair, and disease recovery or remission is judged by the investigator, inclusion is allowed. 7. Symptomatic congestive heart failure (New York Heart Association Class II-IV). Poorly controlled arrhythmias. 8. Active pulmonary tuberculosis undergoing anti-tuberculosis treatment. 9. Interstitial lung disease. 10. Severe infection in the active stage or poorly controlled. Patients hospitalized for severe infections, including but not limited to infections, bacteremia, or complications of severe pneumonia within 3 weeks before treatment. 11. Patients with central nervous system metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal diseases. 12. Human immunodeficiency virus (HIV) infection, known syphilis infection. 13. Administration of live vaccines within 4 weeks of first use of investigational drugs or planned administration of live vaccines during the study period. 14. Known or suspected allergy to investigational drugs or any drugs related to this trial. 15. Pregnant or lactating female patients. 16. Other conditions deemed inappropriate for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival (EFS);Pathological Complete Response (pCR) rate;Major Pathological Response (MPR) rate;R0 Resection Rate;R1 Resection Rate;Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactYupei,Zhao Taiping,Zhang
Peking Union Medical College Hospital
Outcome results
None listed