NCT06511726

Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

Induction Chemotherapy Plus Cadonilimab Followed by Chemoradiotherapy for Locally Advanced Cervical Cancer: A Multicenter, Open-label, Single-arm, Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II clinical study for patients with locally advanced cervical cancer, aimed at evaluating the efficacy, safety, and tolerability of Cadonilimab combined with chemotherapy as induction therapy.

Detailed description

This is a Phase II clinical study for patients with locally advanced cervical cancer, aimed at evaluating the efficacy, safety, and tolerability of Cadonilimab combined with chemotherapy induction therapy, as well as exploring the correlation between the expression level of PD-L1 in tumor samples, changes in blood and tumor-local immune-related factors and cells during treatment, and the efficacy of Cadonilimab induction therapy. The study is divided into two stages, with the first stage requiring the enrollment of 9 patients. If the number of effective cases is ≤7, the trial will be terminated; if \>7 cases, it will proceed to the second stage, continuing to enroll patients until reaching 29. The Cadonilimab dosing regimen involves immunotherapy combined with chemotherapy induction, Cadonilimab and cisplatin and albumin-bound paclitaxel, for a total of 2 cycles. The radiotherapy and chemotherapy regimen includes cisplatin 30-40 mg/m2, once weekly for 5 times, external radiation (6MV-X-ray) at a dose of 45-60Gy/25F; and brachytherapy at a dose of 30Gy/5F. The primary endpoint of the study is ORR, with secondary endpoints being OS, PFS, and DCR.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Cadonilimab	Induction chemotherapy and immunotherapy: Cadonilimab + cisplatin + albumin-bound paclitaxel, for a total of 2 cycles (cisplatin 75 mg/m² + albumin-bound paclitaxel 260 mg/m² q3w, Cadonilimab 10 mg/kg q3w).

Timeline

• Start date: 2024-01-23
• Primary completion: 2025-10-30
• Completion: 2027-10-30
• First posted: 2024-07-22
• Last updated: 2025-02-14

Locations

1 site across 1 country: China