Efficacy and safety of anlotinib hydrochloride combined with concurrent radiotherapy in the treatment of locally advanced cervical cancer: a single-arm, single-center, exploratory, phase II clinical study.

Objective: This study aims to evaluate the therapeutic efficacy and safety of anlotinib, a multitarget tyrosine kinase inhibitor, combined with radiotherapy in patients with locally advanced cervical cancer (LACC). Methods: A prospective single-center study enrolled 62 eligible LACC patients (intention-to-treat [ITT] population) between May 2023 and January 2024, with 53 completing the full treatment course (per-protocol [PP] population). Patients received anlotinib (10 mg/day, days 1-14, 21-day cycles) combined with intensity-modulated radiotherapy (IMRT) and intracavitary brachytherapy. Efficacy was assessed using RECIST v1.1 criteria, including objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Safety was evaluated by monitoring adverse events. Cox regression analyses identified factors influencing PFS, with subgroup analyses by FIGO stage (I-III vs. IV). Results: In the PP population, ORR was 41.51% (5.66% complete response [CR], 35.85% partial response [PR]), and DCR was 83.02%. The ITT population showed lower ORR (35.48%) and DCR (70.97%). Common adverse events included fatigue (28.30%), hypothyroidism (22.64%), and diarrhea (22.64%), with manageable severity. Cox regression revealed that age, diabetes, hypertension, cancer history, and metastatic status significantly influenced PFS. Subgroup analyses showed no statistical differences in efficacy (ORR, DCR) between Stage I-III and IV patients, though Stage IV patients experienced earlier progression. Conclusion: Anlotinib combined with radiotherapy demonstrates promising efficacy and acceptable safety in LACC, with a favorable DCR. The multi-target mechanism of anlotinib may contribute to consistent efficacy across different FIGO stages, supporting its potential as a therapeutic option for LACC. Larger-scale trials are warranted to validate these findings.