NCT06209294

Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery

Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery for Stage IB2-IB3 Cervical Cancer (FIGO 2018)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xiaohua Wu · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II study of neoadjuvant therapy of AK104 combined with nab-paclitaxel/carboplatin in fertility saving surgery for stage IB2-IB3 cervical cancer (FIGO 2018). The main questions it aims to answer are: * · Evaluate the safety of AK104 combined with nab-paclitaxel/carboplatin in the neoadjuvant treatment of cervical cancer * · Evaluate the tumor regression and Major Pathological Response(MPR) of AK104 combined with nab-paclitaxel/carboplatin as neoadjuvant therapy for cervical cancer.

Conditions

• Neoadjuvant Immunotherapy
• Cervical Cancer
• Fertility-sparing Surgery

Interventions

Type	Name	Description
DRUG	AK104	AK104(10 mg/kg) d1,22
DRUG	Carboplatin	AUC=2 d1,8,15,22, 29, 36
DRUG	Nab paclitaxel	125mg／m2 d1,8,15,22,29,36

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-12-30
• Completion: 2028-12-30
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: China