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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Endometrial cancer initially diagnosed as stage III non-operable resectable, stage IV (FIGO, 2009 criteria) after imaging evaluation

• Pathologically confirmed endometrial cancer that looks like endometrial carcinoma

• Patient age ≥18 years and ≤75 years old

• ECOG status score of 0-1

• tolerate surgery and radiotherapy

• Laboratory tests: WBC ≥3.5×109/L, NEU ≥1.5×109/L, PLT ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L.

• ×109/L, serum bilirubin ≤1.5 times the high limit of normal value, transaminase ≤1.5 times the high limit of normal value, BUN ≤1.5 times the high limit of normal value.

⁃ 5 times of the high limit of normal value, BUN, Cr≤normal value;

• Able to follow up and good compliance;

• Able to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and the program.

Locations
Other Locations
China
Women's hospital school of medicine zhejiang university
RECRUITING
Hangzhou
Contact Information
Primary
Yang Li, PHD
li_yang@zju.edu.cn
0086-0571-87061501
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2031-12-01
Participants
Target number of participants: 39
Treatments
Experimental: Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma
Patients with advanced endometrial cancer were enrolled for 2-3 cycles of neoadjuvant chemotherapy in combination with camrelizumab, with imaging to assess efficacy; intermittent subtractive surgery (transabdominal hysterectomy + bilateral adnexectomies + pelvic lymph node dissection + pelvic and abdominal tumors resections +/- para-abdominal aortic lymph node dissection) was performed in patients with complete remissions (CR)/partial remissions (PR), and continued with 3-4 cycles of neoadjuvant chemotherapy in combination with camrelizumab.
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Wenzhou Medical University, Henan Provincial People's Hospital, Zhejiang Cancer Hospital, Tongji Hospital, Ningbo No. 1 Hospital, Xiangya Hospital of Central South University, Anhui Provincial Cancer Hospital
Leads: Women's Hospital School Of Medicine Zhejiang University

This content was sourced from clinicaltrials.gov