Study of Surufatinib With Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel Alone for First Treatment of Advanced or Metastatic Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of surufatinib combined with gemcitabine and nab-paclitaxel chemotherapy compared to gemcitabine and nab-paclitaxel alone in treating patients with locally advanced or metastatic pancreatic cancer. This phase 2, single-center, prospective study includes patients who have previously received two cycles of AG chemotherapy without disease progression. The goal is to assess how these treatments affect disease progression and patient survival. Participants are divided into two groups one receives surufatinib orally every day along with gemcitabine and nab-paclitaxel given intravenously on days 1 and 8 every three weeks, while the other group receives gemcitabine and nab-paclitaxel alone on the same schedule. Treatment continues until disease progression, unacceptable side effects, death, or withdrawal. Dosage adjustments are permitted based on protocol guidelines. Imaging scans are performed every six weeks to monitor tumor status. During the study, patients undergo regular evaluations including tumor imaging using RECIST 1.1 criteria, laboratory tests, vital sign checks, and electrocardiograms to monitor safety and treatment response. Researchers measure progression-free survival as the primary outcome, along with tumor response rates, overall survival, and disease control rates. The study continues until disease progression or death, with safety observed throughout. Participation duration varies based on individual treatment response and tolerance.

A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With AG or AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer