Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer
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
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;
Single group
Camrelizumab
DrugCamrelizumab is administered at 200mg, q3w，intravenous infusion
Carboplatin
DrugAUC=5，q3w，intravenous infusion
Paclitaxel
Drug175 mg/m2，q3w，intravenous infusion, administered over 30min.
Surgery
Procedure/SurgeryTransabdominal hysterectomy + bilateral adnexectomy + pelvic lymph node dissection + pelvic-abdominal tumor resection +/- para-abdominal aortic lymph node dissection
Pathologic complete response
Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis
Surgical complication rate
intraoperative bleeding, vascular injuries, bladder injuries, rectal injuries, and ureteral injuries, as defined by the need for suture repair; occlusive nerve injuries, as defined by complete severance; and vascular injuries, as defined by the need to document the site of injury. Postoperative complications included: ureteral/bladder/rectal/vaginal fistula, internal hemorrhage, pelvic infection, lymphocyst, lymphatic fistula, lower extremity edema, lower extremity venous thrombosis, urinary retention, nerve injury, and bowel obstruction.
Adverse Event
Adverse Effects of immunotherapy and chemotherapy
Remission rate (%) as assessed by RECIST 1.1 criteria
Subjects were assessed for complete and partial remission rates according to RECIST 1.1 criteria
Event-free survival (EFS)
the time between the date of surgery to any documented tumor progression, recurrence, or death from any cause; the analysis of EFS includes the results of tumor evaluations during the study treatment and follow-up periods. If a patient had several indicators of PD or recurrence, the EFS analysis was performed using the indicator that appeared first; PD, recurrence, or death were considered to have reached the study endpoint; patients who were treated with other systemic or antitumor therapies directed at the target lesion of observation were also considered to be in PD; for patients who did not have PD, recurrence, or death at the end of the study, the time when the patient's failure to have a recurrence was last obtained was used as the time to censor the data.
Change in Peripheral Lymphocyte Subsets
Change from baseline in peripheral lymphocyte subsets (CD4+, CD8+, NK, and Treg) as assessed by single-cell sequencing of blood samples.
Change in Tumor Cell PD-L1 Expression
Change from baseline in tumor cell PD-L1 expression, assessed by immunohistochemistry using the Combined Positive Score (CPS) in paired pre-treatment biopsy and post-surgical specimens.
Change in Tumor-Infiltrating Lymphocyte Density
Change from baseline in CD8+ tumor-infiltrating lymphocyte (TIL) density and other immune-related biomarkers within the tumor microenvironment, assessed by immunohistochemistry in paired pre- and post-treatment specimens.
Pathological Response by Molecular Subtype
Pathological complete response (pCR) rate, defined as the absence of viable tumor cells in the resected specimen, evaluated according to molecular subtype (POLE-mutated, MMR-deficient, p53-abnormal, or NSMP).
Click on the lead sponsor to view all of their trials.
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
Tianjin Medical University General Hospital
Collaborator