NCT06561308

Clinical Efficacy Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer

A Single-arm, Multicenter Phase II Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer in Clinical Efficacy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer

Detailed description

Conduct domestic multicenter, prospective phase II single arm clinical trials to answer the following questions： 1. Evaluate the impact of neoadjuvant chemotherapy combined with camrelizumab on the remission rate, surgical complications, and surgical resection rate of advanced stage III-IV endometrial cancer; 2. Evaluate the effect of of neoadjuvant chemotherapy combined with camrelizumab on the survival of patients with advanced III-IV endometrial cancer; 3. Exploring the changes in tumor local immune related factors and cells before and after neoadjuvant chemotherapy and camrelizumab use, as well as the responsiveness of different molecular subtypes of endometrial cancer to neoadjuvant therapy, and screen for biological indicators that predict the effectiveness of camrelizumab.

Conditions

• Endometrioid Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab is administered at 200mg, q3w，intravenous infusion
DRUG	Carboplatin	AUC=4-6，q3w，intravenous infusion
DRUG	Paclitaxel	175 mg/m2，q3w，intravenous infusion, administered over 30min.
PROCEDURE	Surgery	Transabdominal hysterectomy + bilateral adnexectomy + pelvic lymph node dissection + pelvic-abdominal tumor resection +/- para-abdominal aortic lymph node dissection

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-01
• Completion: 2031-12-01
• First posted: 2024-08-20
• Last updated: 2025-12-01

Locations

1 site across 1 country: China