This is an investigator-initiated, single-arm, phase II clinical study evaluating the efficacy and safety of cadonilimab combined with induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced cervical cancer (LACC). Despite standard concurrent chemoradiotherapy, patients with LACC remain at high risk of recurrence and distant metastasis. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, has demonstrated promising antitumor activity in cervical cancer. This study aims to investigate whether induction immunochemotherapy with cadonilimab combined with cisplatin and albumin-bound paclitaxel can improve tumor response before definitive radiotherapy. In addition, the study will explore the association between treatment efficacy and dynamic changes in PD-L1 expression, peripheral blood immune-related biomarkers, and tumor microenvironment immune cell populations during treatment. The primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1, while secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
This is an investigator-initiated, single-arm, phase II clinical study designed to evaluate the efficacy, safety, and tolerability of cadonilimab combined with induction chemotherapy in patients with locally advanced cervical cancer (LACC). The study also aims to explore the association between treatment efficacy and dynamic changes in PD-L1 expression, peripheral blood immune-related biomarkers, and tumor microenvironmental immune cell populations during treatment. A Simon two-stage design is adopted in this study. In the first stage, 9 patients will be enrolled. If 7 or fewer patients achieve an objective response, the study will be terminated for futility. Otherwise, the study will proceed to the second stage, with continued enrollment up to a total sample size of 29 patients. Patients will receive induction immunochemotherapy consisting of cadonilimab combined with cisplatin and albumin-bound paclitaxel for 2 cycles, followed by concurrent chemoradiotherapy (CCRT). During CCRT, cisplatin will be administered weekly at a dose of 30-40 mg/m² for 5 cycles. External beam radiotherapy (EBRT) will be delivered using 6-MV X-rays at a total dose of 45-60 Gy in 25 fractions, followed by brachytherapy with a prescribed dose of 30 Gy in 5 fractions. The primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and treatment tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Cadonilimab will be administered intravenously in combination with cisplatin and albumin-bound paclitaxel as induction immunochemotherapy for 2 cycles.
Cisplatin will be administered during induction chemotherapy and weekly during concurrent chemoradiotherapy.
Albumin-bound paclitaxel will be administered intravenously in combination with cadonilimab and cisplatin during induction therapy.
External beam radiotherapy will be delivered using 6-MV X-rays at a total dose of 45-60 Gy in 25 fractions, followed by brachytherapy at a dose of 30 Gy in 5 fractions. Weekly cisplatin (30-40 mg/m²) will be administered concurrently during radiotherapy.
Sun Yat-sen Memorial hosipital
Guangzhou, Guangdong, China
ORR
At 2 weeks post-induction therapy, objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.
Time frame: up to18 months
OS
Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives.
Time frame: up to approximately 46 months
PFS
Progression-free survival measures the length of time during and after treatment that a patient lives with the disease without it progressing.
Time frame: up to approximately 46 months
DCR
DCR is the proportion of patients who have achieved complete response, partial response, or stable disease
Time frame: up to approximately 46 months
Incidence of treatment-related adverse events (TRAEs)
The proportion of patients experiencing treatment-related adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From initiation of induction therapy to 90 days after completion of radiotherapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.