Elemene Liposomes in Endometrial Cancer

NCT07738315 | Not Yet Recruiting Phase 2

• 1 other identifier: IRB-20250046-R
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Carcinoma

Keywords

Elemene; carboplatin; paclitaxel; advanced endometrial cancer; recurrent endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1

  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.

  24 months from randomization

Secondary Outcomes (5)

• 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.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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, 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: Elemene Injection/Elemene Oral Emulsion; Drug: Carboplatin-Paclitaxel chemotherapy

Control Group

ACTIVE COMPARATOR

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

Drug: Carboplatin-Paclitaxel chemotherapy

Interventions

Elemene Injection/Elemene Oral Emulsion DRUG

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.

Also known as: Elemene

Experimental Arm

Carboplatin-Paclitaxel chemotherapy DRUG

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

Also known as: TC

Control Group; Experimental Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Beijing Friendship Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Jiaxing Maternity and Child Health Care Hospital: collaborator
• Jiangxi Maternal and Child Health Hospital: collaborator
• Fujian Maternity and Child Health Hospital: collaborator
• Ningbo Women & Children's Hospital: collaborator

Study Sites (1)

Women's hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

elemene

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yang Li

CONTACT

0086-0571-87061501; li_yang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CN (1)