Retlirafusp Alfa Combined With Famitinib, Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Unresectable Pancreatic Cancer

Summary

This is a single-arm, prospective, multicenter, open-label clinical trial, which aims to observe and evaluate the efficacy and safety of Relafen-α combined with famitinib and AG chemotherapy as first-line therapy in patients with unresectable pancreatic cancer. The study enrolls patients with unresectable locally advanced and metastatic pancreatic cancer. Progression-free survival (PFS) is set as the primary efficacy endpoint. Approximately 88 patients with unresectable locally advanced and metastatic pancreatic cancer will be recruited. After adequate informed consent and signature of the informed consent form, eligible screened subjects will receive Relafen-α in combination with famitinib plus nab-paclitaxel/gemcitabine. Treatment regimen： Relafen-α (1800 mg, q3w, Cycle 1); Famitinib (15 mg, qd, q3w); nab-paclitaxel (125 mg/m², d1, d8, Q3W, for 6 cycles) combined with gemcitabine (1000 mg/m², d1, d8, Q3W, for 6 cycles). Treatment will be continued until disease progression or intolerable toxicity, whichever occurs first.

Timeline

Start

2026-08-31

Primary completion

2027-08-31

Completion

2029-08-31

Drugs

Indications