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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab+Carboplatin+Paclitaxel | Experimental | Tislelizumab 200mg D1 +Carboplatin(AUC=5) D1+Paclitaxel(175 mg/m2 ) D1, every 3 weeks (21 days) is a treatment cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab 200mg D1 ,Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 24 months |
| Objective Response Rate (ORR%) |
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Inclusion Criteria:
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;
Has not received any systematic anti-tumor treatment for advanced diseases in the past;
Have measurable disease according to RECIST v1.1 criteria;
Patients must meet the following criteria for laboratory tests to ensure adequate organ function:
The expected lifespan exceeds 3 months.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Hu, MD,PhD | Contact | 13632120686 | Huzheng1988@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zheng Hu, MD,PhD | Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Central Hospital of Wuhan | Wuhan | Hubei | 430014 | China |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel |
| Drug |
Paclitaxel(175 mg/m2 ) D1,Q3W |
|
| Carboplatin | Drug | Carboplatin(AUC=5) D1,Q3W |
|
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. |
| 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. | 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. | Up to approximately 24 months |
| Overall survival (OS) | OS is defined as time from first dose of study intervention to death from any cause. | Up to approximately 24 months |
| Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0 | Safety and tolerability | Up to approximately 24 months |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430062 | China |
|
| Hubei maternal and child health care hospital | Wuhan | Hubei | 430070 | China |
|
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |