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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Subjects with an active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for: vitiligo, alopecia areata, Graves' disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;

Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or any treatment directed against immune co-stimulators (e.g., antibodies directed against ICOS, CD40, CD137, GITR, OX40 targets, etc.) that target any mechanism of immune action against tumors;

Known hypersensitivity to any component and/or any excipient of the trial regimen;

Immunosuppressive drugs or systemic corticosteroids for immunosuppression (>10 mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;

Trial design

Treatments tested in this trial

  • Camrelizumab
  • Carboplatin
  • Paclitaxel
  • Surgery

Treatment groups

39 Participants
are divided into 1 treatment group

Sponsors and collaborators

Women's Hospital School Of Medicine Zhejiang University

Lead sponsor

Xiangya Hospital of Central South University

Collaborator

Tongji Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Anhui Provincial Cancer Hospital

Collaborator

Sichuan Cancer Hospital and Research Institute

Collaborator

Henan Provincial People's Hospital

Collaborator

Hunan Cancer Hospital

Collaborator

Zhejiang Cancer Hospital

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Ningbo No. 1 Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator