Efficacy and Safety of Low-Dose Lenvatinib and Toripalimab in Patients With Recurrent Platinum-Resistant Ovarian Cancer: Study Protocol of a Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial

International Journal of Women s Health, Journal Year: 2025, Volume and Issue: Volume 17, P. 325 - 333

Published: Feb. 1, 2025

Purpose: Therapeutic options for patients with platinum-resistant ovarian cancer (PROC) remain a major unmet need. PROC multiple recurrences are unable to continue highly toxic treatment after prior lines of systemic therapy. Chemotherapy-free option lenvatinib plus anti-programmed cell death protein-1 (PD-1) combination therapy has shown promising results in several malignancies including cancer, but the toxicity high starting dose is also notable and needs be improved. Our previous pilot study indicated that reduced may maintain comparable anti-tumor activity favorable safety heavily pre-treated cancer. This designed further validate efficacy low-dose PD-1 inhibitor toripalimab recurrent PROC. Study Design Methods: The as multicenter, open-label, single-arm, prospective phase II study. Patients epithelial who have disease progression either during or within 6 months completion platinum-based will included. A total 69 participants receive (8 mg 12 mg, daily, orally, based on patient's body weight) (240 every 21 days, intravenously). Treatment until development unacceptable progression. primary endpoint progression-free survival. secondary endpoints include objective response rate, duration response, control overall survival, patients' quality life. Exploratory objectives aim identify biomarkers molecular signatures predicting prognosis. Keywords: platinum-resistant, immune checkpoint inhibitor, lenvatinib, adjustment

Language: Английский

Reduced dosing of lenvatinib with pembrolizumab for advanced endometrial cancer

Gynecologic Oncology, Journal Year: 2025, Volume and Issue: 196, P. 36 - 41

Published: April 2, 2025

Language: Английский

Amide proton transfer-weighted imaging combined with multiple models diffusion-weighted imaging of endometrial cancer: correlations between multi-modal MRI parameters and HIF-1α expression

Frontiers in Oncology, Journal Year: 2025, Volume and Issue: 15

Published: April 28, 2025

Background Hypoxia inducible factor (HIF-1α) is a major transcriptional regulating gene expression under hypoxic conditions. HIF-1α was closely correlated with the oxygenation status of tumor and could serve as an important biomarker for hypoxia, aggressiveness, or radiation resistance. High contributes to high aggressiveness poor prognosis endometrial cancer. Purpose This study aimed investigate correlations between multimodal MRI parameters (derived from amide proton transfer weighted imaging [APTw], conventional diffusion [DWI], intravoxel incoherent motion [IVIM] kurtosis [DKI]) expression, determine whether can be used quantitative evaluation expression. Study type Retrospective. Population A total 94 patients EC were examined 32 cases finally included in group 40 low according exclusion inclusion criteria. Field Strength/Sequence 3.0T/APTw, DWI, IVIM, DKI Assessment The asymmetry magnetization rate (MTR asym ), apparent coefficient (ADC), pure (D), pseudo (D*), perfusion fraction (f), mean (MK), diffusivity (MD) calculated compared groups. Statistical Test Mann–Whitney U-test; Chi-square test Fisher exact test; logistic regression analysis; Area receiver operating characteristic (ROC) curve (AUC); Delong Pearson Spearman correlation coefficients. significance threshold set at P < 0.05. Result MTR , ADC, D, D*, MK MD values significantly higher than groups, whereas f value lower AUC HIF-1 α evaluated by f, MD, their combination 0.894 (0.740, 0.973), 0.746 (0.568, 0.879), 0.716 (0.528, 0.904), 0.920 (0.772, 0.984), 0.756 (0.578, 0.886), 0.973 (0.851-1.000), respectively. Multivariate analysis revealed that only MK, independent predictors evaluating EC. Conclusion APTw combined multi-model quantitatively evaluate EC, multiple improve efficiency.

Language: Английский