Induction Chemotherapy Plus Cadonilimab Followed by Chemoradiotherapy for Locally Advanced Cervical Cancer: A Multicenter, Open-label, Single-arm, Phase II Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with good compliance.
• Age ≥ 18 years (calculated on the day of signing the informed consent).
• Histologically or pathologically diagnosed with cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) and measurable lesions.
• Initial diagnosis of stage IB3-IVA (according to FIGO 2018 staging).
• ECOG performance score of 0-2.
• Main organ functions meet the protocol criteria within 7 days before treatment.
Locations
Other Locations
China
Sun Yat-sen Memorial hosipital
RECRUITING
Guangzhou
Contact Information
Primary
Lin Ding
real05@126.com
8918565063596
Backup
Jin Yang
kerryyangj@163.com
8918319441813
Time Frame
Start Date: 2024-01-23
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 29
Treatments
Experimental: Cadonilimab plus Cisplatin and Albumin-Bound Paclitaxel as Induction therapy Followed by CCRT
This is a single-arm study. The experimental arm includes 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).
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University