The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer.
This is a multicenter, prospective, single-arm open-label study designed to enhance surgical R0 resection rate, reduce residual lesions, decrease distant metastasis and disease recurrence rates, and prolong the survival of patients with advanced endometrial cancer (stage III-IVb FIGO 2023) by neoadjuvant chemotherapy combined with tislelizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Tislelizumab 200mg D1 ,Q3W
Paclitaxel(175 mg/m2 ) D1,Q3W
Carboplatin(AUC=5) D1,Q3W
The Central Hospital of Wuhan
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei maternal and child health care hospital
Wuhan, Hubei, China
R0 resection rate (R0 %)
R0 resection rate is defined as the percentage of eligible patients that underwent a microscopically complete (or R0) resection. The resection is considered R0 if the inked margin is further than 1 mm distinct from any tumour cells.
Time frame: Up to approximately 24 months
Pathological complete response rate (pCR%)
pCR is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible.
Time frame: Up to approximately 24 months
Objective Response Rate (ORR%)
ORR (either confirmed complete response \[CR\] or partial response \[PR\]) based on RECIST 1.1 will be determined in participants who have measurable disease at study entry.
Time frame: Up to approximately 24 months
Progression free survival (PFS)
PFS is defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause.
Time frame: Up to approximately 24 months
Recurrence free survival (RFS)
RFS is defined as the time from metastasectomy until progression by RECIST 1.1 or death from any cause.
Time frame: Up to approximately 24 months
Overall survival (OS)
OS is defined as time from first dose of study intervention to death from any cause.
Time frame: Up to approximately 24 months
Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0
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Safety and tolerability
Time frame: Up to approximately 24 months