Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer
Conduct domestic multicenter, prospective phase II single arm clinical trials to answer the following questions: 1. Evaluate the impact of neoadjuvant chemotherapy combined with camrelizumab on the remission rate, surgical complications, and surgical resection rate of advanced stage III-IV endometrial cancer; 2. Evaluate the effect of of neoadjuvant chemotherapy combined with camrelizumab on the survival of patients with advanced III-IV endometrial cancer; 3. Exploring the changes in tumor local immune related factors and cells before and after neoadjuvant chemotherapy and camrelizumab use, as well as the responsiveness of different molecular subtypes of endometrial cancer to neoadjuvant therapy,.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Camrelizumab is administered at 200mg, q3w,intravenous infusion
AUC=5,q3w,intravenous infusion
175 mg/m2,q3w,intravenous infusion, administered over 30min.
Women's hospital school of medicine zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGPathologic complete response
Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis
Time frame: At the end of the patient's treatment, up to 1 years.
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.
Time frame: During and after the surgery, up to 2 years.
Adverse Event
Adverse Effects of immunotherapy and chemotherapy
Time frame: 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
Time frame: At the end of the patient's treatment, up to 1 years.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Transabdominal hysterectomy + bilateral adnexectomy + pelvic lymph node dissection + pelvic-abdominal tumor resection +/- para-abdominal aortic lymph node dissection
Time frame: Until the end of the 3-year follow-up period, up to 5 years.
Overall survival (OS)
the time from the start of the time from the date of enrollment to death from any cause
Time frame: Until the end of the 3-year follow-up period, up to 5 years.