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Clinical Trials in China / NCT07738315
Starting soon Phase 2

Elemene Liposomes in Endometrial Cancer

NCT07738315 · tracked via the Priya Life Science China tracker
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Phase
Phase 2
Started
2026-08-01
Last updated
2026-07-31

Condition(s) studied

Endometrial Carcinoma

Investigational drug(s) / intervention(s)

Elemene Injection/Elemene Oral EmulsionCarboplatin-Paclitaxel chemotherapy

Elemene Injection/Elemene Oral Emulsion: 21 day cycle: Elemene Liposomes intravenous infusion 528 mg once daily from day 1 to day 7 for the first 2 cycles, Elemene Emulsion 176 mg orally twice daily from day 1 to day 14 for cycle 3 to cycle 6.

Carboplatin-Paclitaxel chemotherapy: 21 day cycle: Paclitaxel 175 mg/m² intravenous infusion on day 1 for 6 cycles, Carboplatin AUC=5 intravenous infusion on day 1 for 6 cycles

Study summary

The goal of this clinical trial is to learn if Elemene Liposomes, combined with carboplatin and paclitaxel (TC) chemotherapy can improve prognosis in patients with advanced or recurrent endometrial cancer. The main question it aims to answer is:

Does adding Elemene Liposomes to TC chemotherapy can delay disease recurrence time in patients with advanced or recurrent endometrial carcinoma.

Researchers will compare Elemene Liposomes +TC chemotherapy to TC chemotherapy alone to see if Elemene Liposomes, combined with carboplatin and paclitaxel (TC) chemotherapy can improve prognosis in patients with advanced or recurrent endometrial cancer.

Participants will:

* Receive TC Chemotherapy every 21 days, for a total of 6 cycles.
* Take intravenous infusion of Elemene liposome injection every day from day 1 to day 7 of cycle 1 and 2, and take oral Elemene emulsion twice every day, from day 1 to day 14 of cycles 3 to cycle 6. (no intravenous or oral Elemene will be given in comparison group)
* Visit the clinic for checkups and tests once every 21 days during treatment and every 3 to 12 months after the treatment is completed.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Histopathologically confirmed endometrial malignancy via surgery or biopsy, including endometrioid carcinoma, serous adenocarcinoma, clear cell carcinoma, mixed epithelial carcinoma, dedifferentiated/undifferentiated carcinoma, carcinosarcoma, etc. Non-epithelial tumors such as mesenchymal tumors, neuroectodermal tumors and germ cell tumors are excluded. * Treatment-naïve patients with FIGO 2009 stage III-IV disease, or patients with clinically diagnosed recurrent endometrial malignancy (no restriction on the number of recurrences, and no restriction on whether reoperation was performed after recurrence). Patients must not have received chemotherapy, anti-tumor immunotherapy or radiotherapy within 6 months before randomization. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to randomization. * Adequate organ function defined as: white blood cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L, serum total bilirubin ≤1.5×upper limit of normal (ULN), transaminases (alanine aminotransferase, aspartate aminotransferase) ≤1.5×ULN, serum creatinine and blood urea nitrogen ≤1.5×ULN OR calculated creatinine clearance ≥30 mL/min. All laboratory tests shall be performed within 7 days prior to randomization. Left ventricular ejection fraction ≥lower limit of normal (50%) as assessed by Doppler echocardiography. * Negative serum or urine pregnancy test within 7 days before enrollment, and non-lactating status. Exclusion Criteria: * History of other primary malignant tumors within 3 years prior to randomization. * Concurrent participation in another clinical study, except for observational, non-interventional clinical studies. * Uncontrolled concomitant diseases, including but not limited to cardiac disorders, cerebral diseases, hematological diseases, congenital or postoperative hepatic/renal abnormalities; drug and/or alcohol abuse. * Severe postoperative complications that have not fully resolved. * Known allergy or contraindications to the study drugs (Elemene Liposomes Injection, Elemene Emulsion Oral Solution).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Women's hospital School of Medicine Zhejiang University Hangzhou Zhejiang

More Women's Hospital School Of Medicine Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07738315 on ClinicalTrials.gov ↗ ← All trials in China