NCT06391190

Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer

A Prospective Single Arm Trial of Concurrent Chemoradiotherapy (With Albumin-Bound Paclitaxel/Cisplatin) Followed by PD-1 Inhibitor in Locally Advanced Cervical Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer

Detailed description

Patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly Albumin-Bound Paclitaxel and cisplatin), followed by Sintilimab 200mg q3w for 8 cycles.

Conditions

• Locally Advanced Cervical Carcinoma
• Concurrent Chemoradiotherapy
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Albumin-Bound Paclitaxel, cisplatin, Sintilimab	with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation; followed by Sintilimab 200mg Q3W for 8 cycles

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-30
• Completion: 2026-12-30
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

1 site across 1 country: China