About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation and signed informed consent form;
Age ≥18 years;
Eastern Cooperative Oncology Group performance status 0-1;
The International Federation of Gynecology and Obstetrics (FIGO 2023) stage III-IVb of endometrial cancer;
Disqualifiers
Received PD-1 target therapy other than tislelizumab or other antibody or drug therapy that specifically targets T-cell costimulation or checkpoint channels within 6 months before enrollment;
Has human immunodeficiency virus infection, active viral hepatitis, and active tuberculosis infection;
Active leptomeningeal disease or uncontrolled, untreated brain metastases resulting in elevated intracranial pressure;
Major surgical procedures had been performed within 4 weeks before consent was obtained;
Trial design
Single group
Treatments tested in this trial
Tislelizumab
DrugTislelizumab 200mg D1 ,Q3W
Paclitaxel
DrugPaclitaxel(175 mg/m2 ) D1,Q3W
Carboplatin
DrugCarboplatin(AUC=5) D1,Q3W
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Recurrence free survival (RFS)
RFS is defined as the time from metastasectomy until progression by RECIST 1.1 or death from any cause.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: