Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT06561308

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

Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2025-12-01

39

Participants Needed

1

Research Sites

326 weeks

Total Duration

On this page

Sponsors

W

Women's Hospital School Of Medicine Zhejiang University

Lead Sponsor

X

Xiangya Hospital of Central South University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with stage III non-operable resectable or stage IV endometrial cancer by imaging evaluation
  • Pathologically confirmed endometrioid endometrial cancer
  • Female patients aged between 18 and 75 years
  • ECOG performance status score of 0 or 1
  • Able to tolerate surgery and radiotherapy
  • Laboratory tests with WBC ≥ 3.5 x10^9/L, neutrophils ≥ 1.5 x10^9/L, platelets ≥ 80 x10^9/L, and organ function parameters within acceptable limits
  • Able to comply with follow-up and study requirements
  • Able to provide informed consent and comply with the study protocol
Not Eligible

You will not qualify if you...

  • Active or history of autoimmune disease except certain stable conditions like vitiligo, alopecia areata, Graves' disease, psoriasis, eczema, asymptomatic hypothyroidism, type 1 diabetes with stable insulin, or childhood asthma without adult symptoms
  • Prior treatment with immune checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or CTLA-4 antibodies
  • Known allergy to any component of the study treatments
  • Use of immunosuppressive drugs or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 2 weeks before trial dosing
  • Use of herbs or drugs with immunomodulatory effects within 2 weeks before trial
  • Active systemic infections or serious infections within 4 weeks before dosing
  • Untreated chronic hepatitis B or active hepatitis C
  • Active tuberculosis or suspected active tuberculosis
  • Immunodeficiency or HIV positive
  • Active inflammatory bowel disease or history of such disease
  • Known symptomatic interstitial lung disease
  • Live or attenuated vaccine within 4 weeks prior to dosing (except inactivated flu vaccine)
  • Prior bone marrow or solid organ transplant
  • History of primary malignant tumors within 5 years
  • Major surgery or severe trauma within 28 days prior to dosing
  • History of gastrointestinal or female genital fistula
  • Uncontrolled cardiovascular diseases, bleeding disorders, or other significant co-morbidities
  • Pregnant or breastfeeding women or women of childbearing potential not using contraception
  • Participation in other interventional clinical trials
  • Any condition that may increase risk or interfere with study evaluation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Women's hospital school of medicine zhejiang university

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

Y

Yang Li, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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