Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer

This trial is a multicenter, single-arm phase II clinical trial of Utidelone (UTD1) injection combined with gemcitabine in patients with unresectable, advanced pancreatic cancer, and the study will include 6 centers and enroll 92 patients.Patients who met the entry criteria received Utidelone in combination with gemcitabine: Utidelone (utidelone ®) injection: 30 mg/m2, administered daily on Days 1-5, in 21-day cycles; gemcitabine: 1000 mg/m2, administered 3 weeks using (Q3W) on Days 1 and 8, in 21-day cycles; treatment period: 6-8 cycles, or until the patient experienced disease progression or intolerable toxicity or death.Tumor assessments will be performed at baseline and every 6 weeks (± 7 days) after enrollment until disease progression according to response evaluation criteria in solid tumours (RECISTv1.1) criteria.For patients without disease progression, tumor assessments will continue regardless of whether or not the patient discontinues study treatment unless consent is withdrawn.Follow-up data collection, including subsequent anticancer therapy, was to occur until patient death, withdrawal of consent, loss to follow-up, or study termination, whichever came first.Safety assessments assessed the incidence, nature, and severity of adverse events and laboratory abnormalities according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 in the Investigator-Initiated Clinical Trial (IIT) Study UTD1-PC-01 14 in Shanghai First People 's Hospital.Laboratory safety assessments included periodic monitoring of hematology and chemistry.