Phase II Study of Cadonilimab with Radiotherapy for Women with Locally Advanced Cervical Cancer Who Cannot Tolerate Chemotherapy

What this Trial Is About

Researchers are evaluating the efficacy and safety of Cadonilimab AK104, a humanized IgG1 bispecific antibody targeting PD-1 and CTLA-4, combined with radiotherapy in women with locally advanced cervical cancer who cannot tolerate chemotherapy. This phase II, single-arm, multicenter, open-label study aims to explore treatment options for this specific group of patients. The study is sponsored by Chongqing University Cancer Hospital and focuses on improving outcomes for those with this challenging condition. Participants receive Cadonilimab at a dose of 10 mgkg every three weeks via intravenous infusion. Along with Cadonilimab, they receive radiotherapy that includes external beam radiotherapy EBRT followed by brachytherapy BT. The treatment continues until disease progression, intolerable side effects, withdrawal of consent, or for up to two years. The radiotherapy doses are 45-50.4Gy for EBRT and at least 80Gy for brachytherapy. During the study, participants will be closely monitored with evaluations up to two years for overall response rate. Secondary measures include disease control rate, progression-free survival, overall survival, quality of life assessments using the EORTC QLQ-C30 questionnaire, and recording any adverse events. The total observation period extends up to about 40 months to assess longer-term outcomes and safety.

Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer