Endometrial NeoplasmsNCT06363708
Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer
A study testing Tislelizumab, Paclitaxel and Carboplatin in people with Endometrial Neoplasms, run by Zhongnan Hospital at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms
- What is being tested?
- Tislelizumab, Paclitaxel and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
- The expected lifespan exceeds 3 months.
Who cannot join
- 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；
- Other conditions deemed by the investigator to be ineligible for enrollment.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Xun Tian, MD,PhD, 15327205656, tianxun@126.com
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430062
Zheng Hu, MD,PhD, 13632120686, Huzheng1988@163.com
Hubei maternal and child health care hospital
Wuhan, Hubei, 430070
QuanFu Ma, MD,PhD, 13728133014, dm626925@126.com
About this study
Official title: Tislelizumab Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Endometrial Cancer : A Prospective, Single-arm, Open-label Clinical Study
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.
Read the detailed 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.
- Conditions
- Endometrial Neoplasms
- Being tested
- Tislelizumab, Paclitaxel, Carboplatin
- Keywords
- Oncology, Endometrial Cancer, Tislelizumab
- Medical subject headings
- Endometrial Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab 200mg D1 ,Q3W
PaclitaxelDrug
Paclitaxel(175 mg/m2 ) D1,Q3W
CarboplatinDrug
Carboplatin(AUC=5) D1,Q3W
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 24 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 24 months
Overall survival (OS)
OS is defined as time from first dose of study intervention to death from any cause.
Measured: Up to approximately 24 months
Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0
Safety and tolerability
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zheng Hu, MD,PhD, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363708
- Sponsor's protocol ID
- 2024050
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Endometrial Cancer : A Prospective, Single-arm, Open-label Clinical Study
- ClinicalTrials.gov ID
- NCT06363708
- Acronym / sponsor ID
- 2024050
- Conditions
- Endometrial Neoplasms
- Keywords
- Oncology, Endometrial Cancer, Tislelizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab+Carboplatin+Paclitaxel | Experimental | Drug: Tislelizumab, Drug: Paclitaxel, Drug: CarboplatinTislelizumab 200mg D1 +Carboplatin(AUC=5) D1+Paclitaxel(175 mg/m2 ) D1, every 3 weeks (21 days) is a treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (5 listed)
- 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；
- Other conditions deemed by the investigator to be ineligible for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabTislelizumab 200mg D1 ,Q3W | Drug | Tislelizumab+Carboplatin+Paclitaxel |
| PaclitaxelPaclitaxel(175 mg/m2 ) D1,Q3W | Drug | Tislelizumab+Carboplatin+Paclitaxel |
| CarboplatinCarboplatin(AUC=5) D1,Q3W | Drug | Tislelizumab+Carboplatin+Paclitaxel |
Primary outcome
R0 resection rate (R0 %)
Time frame: Up to approximately 24 months
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.
6 secondary outcomes
Pathological complete response rate (pCR%）
Time frame: Up to approximately 24 months
Objective Response Rate (ORR%)
Time frame: Up to approximately 24 months
Progression free survival (PFS)
Time frame: Up to approximately 24 months
Recurrence free survival (RFS)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 24 months
Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0
Time frame: Up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng Hu, MD,PhD principal investigator
Wuhan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tislelizumab, Paclitaxel and Carboplatin in people with Endometrial Neoplasms, run by Zhongnan Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Hu, MD,PhD (13632120686, Huzheng1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (R0 %) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.