Uterine sarcoma
Conditions
Interventions
Trial group:Doxorubicin 75 mg/m^2, intravenous infusion on day 1 of each cycle, every 3 weeks for 4 cycles
followed by Anruotini 8 mg once daily orally for days 1-14 of each cycle, every 3 weeks for 38 cycles (maintenance phase)
Sponsors
Obstetrics and Gynecology Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed and dated the written Informed Consent Form (ICF) prior to any study-specific procedures, and is able to comply with the protocol-scheduled visits and related procedures. 2. Female subjects, aged >=18 years. 3. Life expectancy >=12 weeks. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 5. Histologically confirmed high-grade uterine sarcoma, including uterine leiomyosarcoma, high-grade endometrial stromal sarcoma, and undifferentiated uterine sarcoma. 6. Has undergone total hysterectomy (bilateral oophorectomy should be performed if the tumor is estrogen receptor positive), resection of any visible intra-abdominal and pelvic metastases, and pathologically confirmed negative surgical margins; no gross residual disease post-surgery. 7. Tumor stage I-II based on imaging and pathology (AJCC, 2017). 8. The time interval between the first dose of study drug and surgery is within 4 weeks. 9. Left Ventricular Ejection Fraction (LVEF) >=50% within 28 days prior to the first dose of study drug. 10. Adequate bone marrow and organ function, with laboratory values meeting the following requirements within 7 days prior to the first dose of study drug (if laboratory tests performed during the screening period do not meet the requirements below, re-testing is allowed only once during the screening period. No cellular, blood component, colony-stimulating factor, or cytokine therapy is allowed within 7 days prior to laboratory testing): (1) Hematology: Absolute Neutrophil Count (ANC) >=1.5×10^9/L or within normal range; Platelet Count (PLT) >=75×10^9/L; Hemoglobin (HGB) >=80 g/L. (2) Hepatic Function: Total Bilirubin (TBIL) =28 g/L. (3) Renal Function: Serum Creatinine (Cr) =60 mL/min (calculated using the Cockcroft-Gault formula or measured via 24-hour urine collection); Urinalysis indicates protein =2+, a 24-hour urine collection should be performed and urine protein should <1g/24h (if both methods are used, the value from the 24-hour urine collection will be used to determine eligibility). (4) Coagulation Function: International Normalized Ratio (INR) <=1.5; Activated Partial Thromboplastin Time (APTT) <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. Histological or cytological findings meeting any of the following conditions: (1) Confirmed carcinosarcoma, low-grade endometrial stromal sarcoma, or perivascular epithelioid cell tumor (PEComa). 2. Participation in any other interventional clinical study; subjects in the follow-up period after the end of study treatment in an interventional study or in an observational (non-interventional) study are excluded. 3. Prior to the first dose of study drug: (1) Received intravenous chemotherapy, macromolecular targeted drugs, antibody-drug conjugates, immunotherapy, endocrine therapy, cell therapy, intraperitoneal chemotherapy, tumor embolization, or interventional chemotherapy within 4 weeks. (2) Received oral chemotherapy, small molecule targeted drugs, and Chinese herbal medicine with anti-tumor indications within 2 weeks or 5 half-lives (whichever is longer). (3) Received radical radiotherapy within 4 weeks; palliative radiotherapy within 2 weeks. (4) Received live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live vaccines) within 4 weeks. 4. Adverse events caused by previous anti-tumor treatments that have not resolved to Grade 0 or 1 according to NCI-CTCAE v5.0 criteria prior to enrollment [excluding Grade 2 alopecia, fatigue, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (e.g., hypothyroidism stably controlled by replacement therapy, hypertension stably controlled below 160/100 mmHg by antihypertensive drugs)]. 5. Pneumonitis requiring corticosteroid therapy, or history of other clinically significant pulmonary diseases (e.g., interstitial lung disease, non-infectious pneumonia), or uncontrolled pulmonary diseases (e.g., pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury), or subjects suspected of having such diseases via imaging during the screening period. 6. Uncontrolled or significant cardiovascular and cerebrovascular diseases, including the following: (1) Uncontrolled myocarditis, or symptomatic congestive heart failure Class II-IV (New York Heart Association [NYHA] criteria), symptomatic or uncontrolled arrhythmias such as ventricular tachycardia, atrial fibrillation, ventricular fibrillation, torsades de pointes, etc. (2) QT interval corrected by Fridericia's formula (QTcF) >480 ms, or personal or family history of congenital long/short QT syndrome. If a single ECG test during screening shows QTcF >480 ms, 3 consecutive ECGs are required to calculate the mean QTcF; if still >480 ms, the subject will not be enrolled. (3) History of any arterial thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the first study treatment. (4) History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to the first dose of study drug (thrombosis caused by implanted venous access ports or catheters, or superficial vein thrombosis are not considered severe thromboembolism). (5) Uncontrolled hypertension despite standard treatment (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg). 7. Esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy), or subjects deemed by the investigator or gastroenterology/hepatology experts to be at high risk of bleeding. Subjects with evidence of portal hypertension (including splenomegaly fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;Incidence of Serious Adverse Events;Incidence of Treatment Discontinuation Due to Adverse Events/Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactWang Yisheng
Obstetrics and Gynecology Hospital Affiliated to Fudan University
Outcome results
None listed