Phase II Randomized Window of Opportunity Trial of Chemoradiotherapy Alone Versus Combination With Metformin in Locally Advanced Cervical Cancer
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.
• Ages 18-70 years old
• Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
• FIGO stage IB2-IVA
• Baseline CT or MRI indicating tumor necrosis (clinical hypoxia)
• Hemoglobin ≥90g/L (blood transfusions allowed); no prior chemotherapy
• ECOG performance status 0-2
• No severe hematopoietic dysfunction, and no significant cardiac, pulmonary, hepatic, renal dysfunction, or immune deficiency
• Able to undergo PET/CT imaging
• Feasible for gynecological examination and cervical biopsy
⁃ Not pregnant or breastfeeding