Elemene Liposomes in Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elemene Injection/Elemene Oral Emulsion, Carboplatin-Paclitaxel chemotherapy.
- Who it may be relevant to
- Registry conditions: Endometrial Carcinoma. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter, Randomized Controlled Trial of Elemene Liposomes Combined With TC Chemotherapy in Advanced or Recurrent Endometrial Cancer
Overview
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.
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
Primary outcome measures
- Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1 [Time frame: 24 months from randomization]
Secondary outcome measures (5)
- Overall Survival Rate at 24 Months [Time frame: 24 months from randomization]
- Remission rate (%) as Assessed by RECIST 1.1 Criteria [Time frame: From randomization to the end of treatment at 18 weeks.]
- Adverse Event [Time frame: From initiation of treatment until the end of the 5-year follow-up period.]
- Patient-Reported Outcome as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [Time frame: From randomization to the end of treatment at 18 weeks.]
- Patient-reported outcome as Assessed by EQ-5D-5L [Time frame: From randomization to the end of treatment at 18 weeks.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Women's hospital School of Medicine Zhejiang University — Hangzhou
Identifiers
NCT: NCT07738315 · IRB-20250046-R