NCT07738315尚未招募2 期
A Prospective, Multicenter, Randomized Controlled Trial of Elemene Liposomes Combined With TC Chemotherapy in Advanced or Recurrent Endometrial Cancer
Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2026年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1
时间窗: 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.
次要结局
- Overall Survival Rate at 24 Months(24 months from randomization)
- Remission rate (%) as Assessed by RECIST 1.1 Criteria(From randomization to the end of treatment at 18 weeks.)
- Adverse Event(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(From randomization to the end of treatment at 18 weeks.)
- Patient-reported outcome as Assessed by EQ-5D-5L(From randomization to the end of treatment at 18 weeks.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Low-Dose Liposomal Amphotericin B for Invasive Fungal Infection Prophylaxis in Neutropenic ChildrenHematopoietic Stem Cell TransplantationNeutropeniaInvasive Fungal InfectionsGraft vs Host DiseaseThalassemiaNCT07725263Haikou Affiliated Hospital of Central South University Xiangya School of Medicine30
招募中
2 期
Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular DiseasesNCT07614477Everest Medicines (China) Co.,Ltd.45
尚未招募
3 期
Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.Colorectal CancerNCT07595276Taizhou Mabtech Pharmaceutical Co.,Ltd608
招募中
3 期
A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)Extensive-stage Small-cell Lung CancerNCT07502300Sichuan Baili Pharmaceutical Co., Ltd.562
尚未招募
2 期
Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical ProstatectomyProstate CancerNCT07415135Zhu Yinjie18