Elemene Liposomes in Endometrial Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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

Первичные конечные точки

• Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1 [Срок оценки: 24 months from randomization]

Вторичные конечные точки (5)

• Overall Survival Rate at 24 Months [Срок оценки: 24 months from randomization]
• Remission rate (%) as Assessed by RECIST 1.1 Criteria [Срок оценки: From randomization to the end of treatment at 18 weeks.]
• Adverse Event [Срок оценки: 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 [Срок оценки: From randomization to the end of treatment at 18 weeks.]
• Patient-reported outcome as Assessed by EQ-5D-5L [Срок оценки: From randomization to the end of treatment at 18 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Women's hospital School of Medicine Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07738315 · IRB-20250046-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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