NCT07088731

Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer

A Prospective, Single-Center, Randomized Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

For locally advanced cervical cancer, there are two main treatment options: One is radical chemoradiotherapy (a combination of radiotherapy and chemotherapy aimed at curing the disease). The other is having neoadjuvant treatment first (treatment given before the main surgery to shrink the tumor) followed by radical surgery. So far, there's no clear answer on which of these two options is better. In general, cervical cancer responds well to immunotherapy. But we still don't know for sure if adding immunotherapy to neoadjuvant chemotherapy can improve the treatment effect for locally advanced cervical cancer, or even make it better than radical chemoradiotherapy. This study aims to compare the effects of two approaches: radical chemoradiotherapy versus neoadjuvant chemotherapy plus immunotherapy followed by surgery.

Conditions

• Cervical Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	neoadjuvent chemotherapy plus sintilimab for 2 cycles followed by radical surgery
RADIATION	Concurrent chemo-radiotherapy	EBRT+BT+cisplatin

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-07-28
• Last updated: 2025-09-22

Locations

1 site across 1 country: China