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

Hongfei Liu^1*Xuezhi Chang¹Ye Hong¹Hao Yin¹Haiyan Zhang¹Gulizhaer wufuer¹Shabiremu Abuduaini¹Yali Jiang^2*

• ¹Tumor Radiotherapy Department, Ili Kazakh Autonomous Prefecture State Friendship Hospital, Yining, China
• ²Ili & Jiangsu Joint Institute of Health, Ili Kazakh Autonomous Prefecture State Friendship Hospital, Yining, China

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.