drugset / Trial / NCT05988372

Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)

NCT05988372

Phase 2 Not yet recruiting 50 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase II Randomized Controlled PILOT clinical study. The purpose of this study is to explore the efficacy and safety of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine in the conversion therapy for patients with unresectable locally advanced pancreatic cancer. Furthermore, it compares the efficacy of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine to the albumin-paclitaxel and gemcitabine regimen in the conversion therapy for patients with unresectable locally advanced pancreatic cancer.

Timeline

Start
2023-10-23
Primary completion
2023-10-23
Completion
2026-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody 4.5 mg/kg Intravenous
Subject Surufatinib Small molecule 250 mg Oral
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous