Endometrial Carcinoma
Conditions
Keywords
Elemene, carboplatin, paclitaxel, advanced endometrial cancer, recurrent endometrial cancer
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.
Interventions
DRUGElemene 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.
DRUGCarboplatin-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
Women's Hospital School Of Medicine Zhejiang University
Beijing Friendship Hospital
The First Affiliated Hospital of Zhengzhou University
Second Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival Rate at 24 Months as Assessed by RECIST v1.1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate at 24 Months | 24 months from randomization | 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. |
| Remission rate (%) as Assessed by RECIST 1.1 Criteria | From randomization to the end of treatment at 18 weeks. | 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. |
| Adverse Event | From initiation of treatment until the end of the 5-year follow-up period. | Adverse Effects of antitumor therapy |
| 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. | 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). |
| Patient-reported outcome as Assessed by EQ-5D-5L | From randomization to the end of treatment at 18 weeks. | 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). |
Countries
China
Contacts
CONTACTYang Li
Outcome results
None listed