Study of mFOLFIRINOX with Anlotinib and Sintilimab for First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer in Adults

What this Trial Is About

Researchers are evaluating a combination treatment for patients with locally advanced or metastatic pancreatic cancer who have not received prior anti-cancer therapy. This prospective, single-arm, multicenter, phase IbII clinical trial aims to assess the safety and effectiveness of mFOLFIRINOX combined with anlotinib and sintilimab. The study also explores how certain biomarkers might relate to treatment outcomes. The trial begins with a phase Ib dose-finding part where 6 patients receive anlotinib at 10 mg daily for 14 days every 3 weeks alongside mFOLFIRINOX and sintilimab. If dose-limiting toxicities occur, a lower dose of anlotinib 8 mg will be tested. Once a safe dose is identified, phase II will proceed using that dose to evaluate the treatments efficacy and safety as a first-line therapy for pancreatic cancer. Participants will be monitored for tumor response starting four weeks after treatment begins, with ongoing assessments for overall survival, progression-free survival, disease control rate, and adverse events over up to 60 months. The study includes evaluations of measurable cancer lesions, regular safety check-ups, and tracking of any side effects. Participants are expected to have an Eastern Cooperative Oncology Group performance status of 0 or 1 and a minimum expected survival of three months during the trial.

mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer