Clinical trial · Interventional
Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer
Tislelizumab Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Endometrial Cancer : A Prospective, Single-arm, Open-label Clinical Study
NCT06363708CI-TRIAL-00075963unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab+Carboplatin+Paclitaxel
- description
- Tislelizumab 200mg D1 +Carboplatin(AUC=5) D1+Paclitaxel(175 mg/m2 ) D1, every 3 weeks (21 days) is a treatment cycle
- interventionNames
- Drug: Tislelizumab
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- R0 resection rate (R0 %)
- timeFrame
- Up to approximately 24 months
- description
- 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 (6)
- measure
- Pathological complete response rate (pCR%)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.