drugset / Trial / NCT05969171

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

NCT05969171

Phase 2 Recruiting 65 enrolled Fudan University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment of patients with locally advanced or metastatic pancreatic cancer. Participants with previously received AG chemotherapy for 2 cycles with no disease progression will be enrolled: Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn; During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during the patient's treatment) or toxicity was intolerable or other criteria for termination of study treatment specified in the protocol were met, and the tumor treatment and survival status after disease progression were recorded. Safety observation indicators include: AEs, changes in laboratory values, vital signs, and changes in electrocardiogram.

Timeline

Start
2023-12-05
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Surufatinib Small molecule 250 mg Oral
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous