drugset / Trial / NCT07625930

RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial

NCT07625930 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

Esophageal and gastroesophageal junction cancers are serious diseases with limited cure rates, even when patients receive chemotherapy and surgery. New ways to improve treatment are urgently needed. This study will test whether adding a commonly used cholesterol-lowering medication, simvastatin, to standard cancer treatment can improve outcomes. Simvastatin is widely used, safe, and inexpensive. Research suggests that it may also slow cancer growth by blocking pathways that cancer cells rely on for survival. In this trial, patients will receive standard chemotherapy (with or without immunotherapy) before surgery. Half of the patients will also take simvastatin daily for up to two years. Researchers will compare how well tumors respond to treatment and whether patients remain cancer-free longer. If successful, this approach could offer a simple and accessible way to improve survival for patients with these cancers without adding significant side effects or cost.

Timeline

Start
2027-01
Primary completion
2029-04
Completion
2031-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule — —
Background Docetaxel Small molecule — —
Background Durvalumab Monoclonal antibody — —
Background Leucovorin Small molecule — —
Background Oxaliplatin Small molecule — —
Background fluorouracil Small molecule — —