Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer

Endometrial Neoplasms Clinical Trial

Official title:

Tislelizumab Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Endometrial Cancer : A Prospective, Single-arm, Open-label Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363708
• Other study ID #: 2024050
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Zhongnan Hospital
• Contact: Zheng Hu, MD,PhD
• Phone: 13632120686
• Email: Huzheng1988[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Voluntary participation and signed informed consent form;

2. Age =18 years;

3. Eastern Cooperative Oncology Group performance status 0-1;

4. The International Federation of Gynecology and Obstetrics (FIGO 2023) stage III-IVb of endometrial cancer;

5. Has not received any systematic anti-tumor treatment for advanced diseases in the past;

6. Have measurable disease according to RECIST v1.1 criteria;

7. Patients must meet the following criteria for laboratory tests to ensure adequate

organ function:

• ANC =1,500/mm3, or =1.5×109/L
• Platelet count=75,000/mm3 or 75 x 109/L
• Hemoglobin=9 g/dL or =5.6 mmol/L
• Glomerular filtration rate estimated(eGFR) according to the Chronic Kidney Disease Epidemiology Collaborative Group formula (CKD-EPI EQ6)was=40 mL/ 1.73m2
• Serum total bilirubin = 1.5x upper limit of normal range(ULN)
• Both AST and ALT were =3 x ULN

8. The expected lifespan exceeds 3 months.

Exclusion Criteria:

1. 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;

2. Has human immunodeficiency virus infection, active viral hepatitis, and active tuberculosis infection;

3. Active leptomeningeal disease or uncontrolled, untreated brain metastases resulting in elevated intracranial pressure;

4. Major surgical procedures had been performed within 4 weeks before consent was obtained;

5. Other conditions deemed by the investigator to be ineligible for enrollment.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Drug:
• Tislelizumab
Tislelizumab 200mg D1 ,Q3W
• Paclitaxel
Paclitaxel(175 mg/m2 ) D1,Q3W
• Carboplatin
Carboplatin(AUC=5) D1,Q3W

Locations

Country	Name	City	State
China	Hubei maternal and child health care hospital	Wuhan	Hubei
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Up to approximately 24 months
Secondary	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
Secondary	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
Secondary	Overall survival (OS)	OS is defined as time from first dose of study intervention to death from any cause.	Up to approximately 24 months
Secondary	Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0	Safety and tolerability	Up to approximately 24 months