drugset / Trial / NCT06353061

Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer

NCT06353061 ↗

Phase 2 Unknown 51 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients.

Timeline

Start
2024-04-15
Primary completion
2025-08-01
Completion
2026-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 850 mg Oral
Background Cisplatin Other / unclassified 40 mg/m2 —

Indications