Clinical Efficacy Study of Pucotenlimab Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer
NCT Number: NCT06561308
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Endometrioid Endometrial Cancer
Interventions: DRUG: Pucotenlimab|DRUG: Carboplatin|DRUG: Paclitaxel|PROCEDURE: Surgery
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Collaborators: Xiangya Hospital of Central South University|Tongji Hospital|Qilu Hospital of Shandong University|Anhui Provincial Cancer Hospital|Sichuan Cancer Hospital and Research Institute|Henan Provincial People's Hospital|Hunan Cancer Hospital|Zhejiang Cancer Hospital|First Affiliated Hospital of Wenzhou Medical University|Ningbo No. 1 Hospital|The First Affiliated Hospital of Zhengzhou University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-12-01
Locations: Women's hospital school of medicine zhejiang university, Hangzhou, Zhejiang, 310000, China

Summary:
Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitors on advanced stage III-IV endometrial cancer

Primary Outcome Measures: Pathologic complete response, Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis, At the end of the patient's treatment, up to 1 years.
Secondary Outcome Measures: 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., During and after the surgery, up to 2 years.|Adverse Event, Adverse Effects of immunotherapy and chemotherapy, during the treatment, up to 5 years.|Remission rate (%) as assessed by RECIST 1.1 criteria, Subjects were assessed for complete and partial remission rates according to RECIST 1.1 criteria, At the end of the patient's treatment, up to 1 years.|Event-free survival (EFS), the time between the enrollment and 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., Until the end of the 3-year follow-up period, up to 5 years.|Overall survival (OS), the time from the start of enrollment to death from any cause, Until the end of the 3-year follow-up period, up to 5 years.