NCT06878196

ctDNA-guided First-line Immuno-de-escalation Therapy for IVB-stage and Recurrent Cervical Cancer

ctDNA-guided First-line Immuno-de-escalation Therapy for Stage IVB and Recurrent Cervical Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the clinical feasibility of first-line immunochemotherapy for stage IVB and recurrent cervical cancer guided by circulating tumor DNA (ctDNA), in order to explore the optimal treatment duration or criteria for discontinuation of first-line immunotherapy in patients with stage IVB cervical cancer or recurrent cervical cancer. To ensure the quality of the study, before the study begins, the research applicant and participants jointly discuss and formulate the research plan. Necessary steps should be taken during the design and implementation stages of the study to ensure that the collected data is accurate, consistent, complete, and credible.

Conditions

• Uterine Cervical Neoplasm

Interventions

Type	Name	Description
DRUG	cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab	Patients with persistent, recurrent, or advanced metastatic cervical cancer who have not received systemic treatment are treated with cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab (treatment dosage: cadonilimab 10 mg/kg, paclitaxel 175 mg/m\^2, cisplatin 50 mg/m\^2, cisplatin AUC 4-5, bevacizumab 7.5-15 mg/kg), once every 3 weeks, for a total of 6 cycles (if the patient continues to benefit, chemotherapy is allowed beyond 6 cycles), followed by maintenance treatment with cadonilab ± bevacizumab.

Timeline

• Start date: 2025-03-10
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-03-14
• Last updated: 2025-03-14

Locations

1 site across 1 country: China