locally advanced pancreatic cancer
Conditions
Interventions
Neoadjuvant therapy group:NALARIFOX scheme
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years, with no restriction on sex; 2. Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), with a diagnosis of locally advanced pancreatic cancer (LAPC) established by imaging studies (contrast-enhanced CT and/or MRI) and multidisciplinary team (MDT) evaluation, according to the NCCN Clinical Practice Guidelines for Pancreatic Cancer (Version 2, 2025); 3. No evidence of distant metastasis; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. Estimated life expectancy >= 6 months; 6. No prior treatment for pancreatic cancer, including surgery, chemotherapy, radiotherapy, or immunotherapy; 7. Deemed suitable for surgical intervention by surgical assessment, with elective surgery planned following completion of neoadjuvant therapy; 8. Adequate organ function, meeting the following laboratory criteria: Absolute neutrophil count (ANC) >= 1.5 × 10?/L; Platelet count >= 100 × 10?/L; Hemoglobin >= 9 g/dL; Total bilirubin = 50 mL/min, calculated using the Cockcroft–Gault formula; 9. Provision of written informed consent, with willingness to comply with the study protocol and follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Evidence of distant metastasis, including but not limited to liver, lung, or peritoneal metastases; 2. Severe gastrointestinal complications, such as active gastrointestinal bleeding, high-grade obstruction, or gastrointestinal perforation, that preclude completion of the planned treatment; 3. Prior treatment for pancreatic cancer, including surgery, radiotherapy, chemotherapy, or immunotherapy; 4. History of other active malignancies, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated within the past 5 years; 5. Active or previously diagnosed autoimmune diseases, including but not limited to systemic lupus erythematosus; 6. Active hepatitis B or hepatitis C infection, defined as HBV DNA > 2,000 IU/mL or positive HCV RNA. Patients with chronic HBV infection may be enrolled if HBV DNA = 10 mg/day for >= 14 consecutive days; 9. Presence of central nervous system (CNS) metastases; 10. Pregnant or breastfeeding women, or women or men planning pregnancy who are unwilling to use effective contraception during the study period; 11. Psychiatric disorders or other serious comorbid conditions that, in the investigator’s judgment, would preclude completion of the study treatment or follow-up; 12. Typical contraindications to chemotherapy, including but not limited to active uncontrolled infection, peripheral neuropathy of grade >= II, or major cardiovascular events occurring within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intention-to-treat (ITT) R0 Resection Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Conversion-to-surgery Rate;Treatment-Related Adverse Events;Overall Survival;Event free survival period;Pathological complete remission rate;Main pathological remission rate; | — |
Countries
China
Contacts
Public ContactAng Li
West China Hospital of Sichuan University
Outcome results
None listed