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NCT07738315

PHASE2

Elemene Liposomes in Endometrial Cancer

Sponsor: Women's Hospital School Of Medicine Zhejiang University

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multicenter, Randomized Controlled Trial of Elemene Liposomes Combined With TC Chemotherapy in Advanced or Recurrent Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

2026-08-01

Completion Date

2031-09

Last Updated

2026-07-31

Healthy Volunteers

Conditions

Endometrial Carcinoma

Interventions

DRUG

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.

DRUG

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

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).

Locations (1)

Women's hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China