NCT06289062

Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer

Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, EFS and OS.

Conditions

• Cervical Cancer
• Neoadjuvant Chemoimmunotherapy
• Fertility Preservation

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
DRUG	Cisplatin	75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
DRUG	Nab paclitaxel	260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
PROCEDURE	biopsy	cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy

Timeline

• Start date: 2024-05-08
• Primary completion: 2025-12-01
• Completion: 2030-12-01
• First posted: 2024-03-01
• Last updated: 2024-11-05

Locations

2 sites across 1 country: China