Efficacy and Safety of Camrelizumab Combined with Concurrent Chemoradiotherapy in Locally Advanced Cervical Cancer: A Phase II Single-Arm Clinical Trial.

AIM: This clinical investigation evaluated the efficacy and safety of the immune checkpoint inhibitor camrelizumab administered with concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

MATERIALS AND

METHODS

This prospective trial enrolled patients aged 18-75 years with previously untreated cervical cancer classified as stage IIB to IVA according to the 2018 International Federation of Gynecology and Obstetrics system. Patients received intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) external-beam radiotherapy combined with three-dimensional brachytherapy, cisplatin chemotherapy, and camrelizumab 200 mg every 3 weeks for up to 1 year. Progression-free survival (PFS) was the primary endpoint; overall survival (OS) was a secondary exploratory endpoint of interest. Secondary endpoints also included treatment safety.

RESULTS

A total of 50 patients were enrolled between February 2021 and July 2022. The majority had International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IIIC1r/IIIC2r (70.0%) disease. The median age was 50.2 years (range, 30-65), and the median follow-up duration was 46.3 months (range, 37.5-55.4 months). The median PFS was not reached, and the 36-month PFS rate was 84.0% (95 % confidence interval [CI]: 73.8-94.2 %) The 36-month OS rate was 100%, and the median OS was not reached. Exploratory subgroup analyses for PFS and OS based on PD-L1 status and FIGO 2018 stage demonstrated favorable survival outcomes across subgroups, with no statistically significant difference between the PD-L1 positive and negative subgroups (log-rank P > 0.05). Treatment-related adverse events occurred in 96% of patients, although grade 3 or higher events were infrequent (0-18.0%), most commonly hematologic toxicity and enteritis. Immune-related adverse events (irAEs) occurred in 92.0% (46/50) of patients, and grade 3 or higher immune-related events occurred in 4.0% (2/50), including one case of conjunctivitis (2.0%, 1/50) and one case of lateral rectus muscle paralysis (2.0%, 1/50). No treatment-related mortalities or cases of irreversible organ damage were observed. An exploratory analysis examining the association between the total EQD2 radiation dose (≥85 Gy vs <85 Gy) and key outcomes (PFS, OS, grade ≥3 toxicities) found no statistically significant associations, likely due to the small sample size. One patient did not complete the 12-cycle imaging assessment on time.

CONCLUSION

In this exploratory phase II single-arm study, camrelizumab administered with concurrent chemoradiotherapy demonstrated promising long-term survival outcomes and manageable toxicities in patients with locally advanced cervical cancer, providing preliminary support for further investigation.