Elemene Liposomes in Endometrial Cancer

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

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

Sponsors & Collaborators

• Beijing Friendship Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital, Zhejiang University, School of Medicine

  collaborator OTHER

• Jiaxing Maternity and Child Health Care Hospital

  collaborator OTHER

• Jiangxi Maternal and Child Health Hospital

  collaborator OTHER

• Fujian Maternity and Child Health Hospital

  collaborator OTHER

• Ningbo Women & Children's Hospital

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2031-08-31

Completion

2031-09-30

Countries

• China

Study Locations