Endometrial Carcinoma
Conditions
Interventions
Interventional Arm:1. Adjuvant Chemotherapy
Timing: Initiated within 6-8 weeks after surgery.
Regimen: Carboplatin (AUC 6) plus paclitaxel (175 mg/m2).
Cycle: Administered every 21 days.
Duration: For
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, female. 2. Histologically confirmed endometrial carcinoma, including endometrioid carcinoma, serous endometrial carcinoma, clear cell carcinoma of the uterus, dedifferentiated and undifferentiated endometrial carcinoma, uterine sarcoma, and mixed endometrial carcinoma. 3.Abnormal p53 protein expression (p53abn) confirmed by immunohistochemistry (IHC) or the presence of a TP53 mutation confirmed by genetic testing. 4. Initiation of adjuvant therapy within 6-8 weeks after undergoing hysterectomy and bilateral salpingo-oophorectomy, with no evidence of disease progression during adjuvant chemotherapy. 5. Presence of postoperative high-risk factors as defined by the 2020 ESGO/ESTRO/ESP guidelines: FIGO stage I-IVA p53abn endometrial carcinoma with myometrial invasion and no residual disease. 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. 7. Adequate organ function, meeting the following laboratory parameters: Hematology:Hemoglobin (Hb) >= 100 g/L.Absolute neutrophil count (ANC) >= 1.5 × 10?/L.Platelet count (PLT) >= 100 × 10?/L. Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 mL/min.Coagulation: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothinal time (PT) <= 1.5 × ULN. 8. Female subjects must have a negative urine or blood HCG test (except those who are postmenopausal or have undergone hysterectomy). Female subjects of childbearing potential and their partners must use highly effective contraception (e.g., combined hormonal contraception containing estrogen and progestogen with inhibition of ovulation, progestogen-only contraception with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomy, or sexual abstinence) during the trial and for 6 months after the last dose of the study drug. 9. Signed informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: 1. Patients with pathogenic POLE variants or mismatch repair deficiency (MMRd). 2. Patients who have previously received chemotherapy or pelvic/abdominal radiotherapy. 3. Prior treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi). 4. Patients with recurrent endometrial carcinoma. 5. History of another invasive malignancy within the past 5 years (except for completely resected basal cell or squamous cell skin carcinoma). 6. History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 7. Prior allogeneic bone marrow transplantation or double umbilical cord blood transplantation (dUCBT). 8. Diseases that may affect the absorption, distribution, metabolism, or excretion of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, or malabsorption syndrome). 9. Presence of ascites or pleural effusion requiring drainage, or having undergone peritoneal or pleural drainage within 2 months prior to the first dose of Senaparib. 10. Significant cardiovascular disease, including but not limited to: Heart failure of New York Heart Association (NYHA) Class II or higher. Unstable angina. Myocardial infarction within the past year. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention. QTc interval > 470 ms. 11. Active infections, including: Positive for human immunodeficiency virus (HIV) (HIV-1/2 antibodies). Active hepatitis C (positive for HCV antibody or HCV-RNA >= 10³ copies/mL with abnormal liver function). Active co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV). Active tuberculosis. Other uncontrolled active infections (grade >2 per CTCAE v5.0). 12. Concurrent use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin). 13. Adverse events from prior chemotherapy (except alopecia) that have not recovered to <= Grade 1 (CTCAE v5.0). 14. History or evidence of hemorrhagic disorders within 6 months prior to enrollment. 15. Psychiatric illness or other conditions (e.g., uncontrolled cardiac or pulmonary disease, diabetes) that would compromise compliance with study requirements or interfere with monitoring. 16. Known hypersensitivity to Senaparib or any of its excipients. 17. Patients deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival (RFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence-free survival rate;overall survival (OS);safety; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center
Outcome results
None listed