Endometrial CarcinomaPhase 2NCT07738315
Elemene Liposomes in Endometrial Cancer
A Phase 2 study testing Elemene Injection/Elemene Oral Emulsion and Carboplatin-Paclitaxel chemotherapy in people with Endometrial Carcinoma, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Carcinoma
- What is being tested?
- Elemene Injection/Elemene Oral Emulsion and Carboplatin-Paclitaxel chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Women's hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial of Elemene Liposomes Combined With TC Chemotherapy in Advanced or Recurrent Endometrial Cancer
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.
Read more
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
- Being tested
- Elemene Injection/Elemene Oral Emulsion, Carboplatin-Paclitaxel chemotherapy
- Keywords
- Elemene, carboplatin, paclitaxel, advanced endometrial cancer, recurrent endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemene Injection/Elemene Oral EmulsionDrug
Also called Elemene
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.
Carboplatin-Paclitaxel chemotherapyDrug
Also called TC
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Carboplatin-Paclitaxel chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months from randomization
Secondary outcomes (5)
Overall Survival Rate at 24 Months
Defined as the probability that patients remain alive at 24 months from randomization estimated via the Kaplan-Meier method. Death from any cause is counted as the endpoint event.
Measured: 24 months from randomization
Remission rate (%) as Assessed by RECIST 1.1 Criteria
The proportion of patients achieving a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 criteria. Only patients with measurable disease at baseline are included in the evaluable population for ORR.
Measured: From randomization to the end of treatment at 18 weeks.
Adverse Event
Adverse Effects of antitumor therapy
Measured: 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
Health information directly reported by patients reflecting health-related quality of life. measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Measured: From randomization to the end of treatment at 18 weeks.
Patient-reported outcome as Assessed by EQ-5D-5L
Health information directly reported by patients, reflecting symptoms, function and health-related quality of life as Assessed by EuroQol Five-Dimensional Five-Level Questionnaire (EQ-5D-5L).
Measured: From randomization to the end of treatment at 18 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Jiaxing Maternity and Child Health Care Hospital, Jiangxi Maternal and Child Health Hospital, Fujian Maternity and Child Health Hospital, Ningbo Women & Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738315
- Sponsor's protocol ID
- IRB-20250046-R
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial of Elemene Liposomes Combined With TC Chemotherapy in Advanced or Recurrent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07738315
- Acronym / sponsor ID
- IRB-20250046-R
- Conditions
- Endometrial Carcinoma
- Keywords
- Elemene, carboplatin, paclitaxel, advanced endometrial cancer, recurrent endometrial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Jiaxing Maternity and Child Health Care Hospital, Jiangxi Maternal and Child Health Hospital, Fujian Maternity and Child Health Hospital, Ningbo Women & Children's Hospital
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Elemene Injection/Elemene Oral Emulsion, Drug: Carboplatin-Paclitaxel chemotherapy21 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. |
| Control Group | Active comparator | Drug: Carboplatin-Paclitaxel chemotherapy21 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elemene Injection/Elemene Oral EmulsionAlso: Elemene21 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 | Experimental Arm |
| Carboplatin-Paclitaxel chemotherapyAlso: TC21 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 | Control Group, Experimental Arm |
Primary outcome
Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1
Time frame: 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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elemene Injection/Elemene Oral Emulsion and Carboplatin-Paclitaxel chemotherapy in people with Endometrial Carcinoma, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Li (0086-0571-87061501, li_yang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1 (time frame: 24 months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.