Health TrialsbyHealthPanel

Elemene Liposomes in Endometrial Cancer

ConditionEndometrial Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
24 months from randomization

Secondary outcomes

1

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.

Time frame
24 months from randomization
2

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.

Time frame
From randomization to the end of treatment at 18 weeks.
3

Adverse Event

Adverse Effects of antitumor therapy

Time frame
From initiation of treatment until the end of the 5-year follow-up period.
4

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).

Time frame
From randomization to the end of treatment at 18 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women's Hospital School Of Medicine Zhejiang University

Lead sponsor

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: