A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer

Prior treatment

• Major surgery within 4 weeks before first dose of study drug (except puncture biopsy), or unhealed, infected, or dehisced surgical wound.
• Participation in any clinical trial or receipt of any approved antitumor drug within 4 weeks before screening.

Other illness

• Other primary malignancies besides pancreatic cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
• History of allergy to the study drugs, similar structural compounds, or their components.
• Known HIV or syphilis infection, or current active hepatitis B or C. Active hepatitis B is defined as HBsAg positive with HBV DNA >1000 copies/mL; active hepatitis C is defined as anti-HCV positive with HCV RNA >1000 copies/mL.
• History of severe gastrointestinal disease, such as gastrointestinal bleeding within the past year (e.g., gastric ulcer bleeding or esophageal variceal bleeding), active ulcerative colitis, or Crohn's disease (irinotecan may induce diarrhea, and such underlying diseases may increase toxicity).
• Other conditions judged by the investigator as unsuitable for this study (e.g., severe malnutrition, psychiatric illness preventing follow-up cooperation, or planned receipt of other antitumor therapy during the study).

Lab values

• Other severe diseases, including but not limited to: uncontrolled congestive heart failure (NYHA class III or IV), unstable angina, poorly controlled arrhythmia, uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg); active infection; poorly controlled diabetes (fasting blood glucose persistently >9.0 mmol/L or HbA1c >7.5% despite glucose-lowering treatment); uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension (e.g., esophageal or gastric varices with a history of bleeding) or portal cavernoma on imaging; gastrointestinal obstruction (including gastric outlet or duodenal obstruction requiring decompression or stenting); respiratory insufficiency (requiring oxygen at rest or arterial oxygen partial pressure <60 mmHg).

Other

• Untreated biliary obstruction.
• Pregnant or lactating women.

• Age 18-75 years, male or female.
  • Histologically and/or cytologically confirmed pancreatic adenocarcinoma.
  • Radiologically confirmed locally advanced or metastatic pancreatic cancer that is not amenable to curative surgery (assessed according to NCCN criteria).
  • ECOG performance status 0-1, and the investigator considers the patient able to tolerate the NALIRIFOX regimen.
  • No prior systemic therapy for pancreatic cancer (including chemotherapy, targeted therapy, or immunotherapy). Prior neoadjuvant or adjuvant therapy is allowed only if recurrence/progression occurred more than 6 months after the last dose and prior treatment-related toxicity has recovered to Grade ≤1 per CTCAE 5.0 (except alopecia or other toxicity judged by the investigator to have no safety risk).
  • At least one measurable lesion per RECIST 1.1. Target lesions must not have received prior radiotherapy or other local therapy; a lesion in a previously irradiated area may be selected as a target lesion if progression has been confirmed and it meets RECIST 1.1 criteria.
  • Adequate organ and bone marrow function: hemoglobin ≥9.0 g/dL; absolute neutrophil count ≥1.5 × 10\^9/L; platelet count ≥100 × 10\^9/L; total bilirubin ≤1.5 × ULN (≤3 × ULN if liver metastasis); AST and ALT ≤2.5 × ULN (≤5 × ULN if liver metastasis); serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
  • Life expectancy of at least 3 months.
  • Women of childbearing potential must agree to use medically accepted contraception during the study.
  • Good compliance and willingness to sign the informed consent form.