Elemene Liposomes in Endometrial Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1 — 24 months from randomization
The probability that a patient remains free of documented disease progression (per RECIST 1.1 ) or death from any cause at 24 months after randomization estimated via the Kaplan-Meier method.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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