ovarian cancer
Conditions
Interventions
one arm:SHR6390 + NSAI +/- OFS
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female subjects aged 18 to 70 years old, meet any of the following: (1) Both ovaries have been removed, or the aged >=60 years old; (2) Aged =10%); 3. Patients with a histologic or cytologic diagnosis of epithelial ovarian cancer or uterine tumor , except for pure clear cell or mucinous cancer; 4. Previous treatment: (1) Initial platinum-resistant high-grade serous ovarian, the number of previous chemotherapy is not limited; (2) Initial platinum-resistant endometrioid ovarian cancer, the number of previous chemotherapy is not limited; (3) Low-grade serous ovarian cancer progressed after first-line treatment; (4) Endometrial cancer progressed after first-line treatment; (5) High-grade endometrial stromal sarcoma, undifferentiated uterine sarcoma and uterine leiomyosarcoma that progressed after first-line treatment; (6) Low-grade endometrial stromal sarcoma that has not received systemic treatment for recurrent and metastatic disease; 5. Patients with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1; 6. Willing to accept biopsy; 7. ECOG performance status score 0 or 1; 8. The expected survival period is not less than 12 weeks; 9. Adequate function of major organs meets the following requirements: (1) Blood routine: ANC>=1.5x10^9/L; PLT>=75x10^9/L; PLT>=100x10^9/L; Hb>=90 g/L; (2) Blood biochemistry: TBIL=50 mL/min (Cockcroft-Gault formula); (3) Cardiac ultrasound: LVEF>=50%; (4) 12-lead ECG: Fritzia-corrected QT interval (QTcF) <470ms; 10. Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Symptomatic and/or uncontrolled central nervous system or pial metastasis, except for both of the following two conditions: (1) The treatment for brain metastases (including radiation and/or surgery) is at least 4 weeks apart from completion to the beginning of the study treatment; (2) It appears as a clinically stable tumor during screening, and does not require steroid and/or antiepileptic treatment; 2. Have ascites; 3. Previously received any CDK4/6 inhibitor and/or aromatase inhibitor (letrozole, anastrozole or exemestane) treatment; 4. Underwent surgery within 14 days before enrollment or had not recovered from the surgical trauma (except for biopsy); 5. Participated in other drug clinical trials or received systemic chemotherapy/ radiotherapy within 4 weeks before enrollment; 6. Concurrent use of any other Anti-cancer treatment; 7. History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Any heart diseases that investigator believes not suitable for this study; 8. History of allergy or hypersensitivity to any of the study drugs or study drug components; history of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation; 9. Suffering from gastrointestinal diseases such as intestinal obstruction, peptic ulcer or active bleeding, which affects the taking and absorption of drugs; 10. A clear history of neurological or mental disorders, including epilepsy or dementia; 11. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation; 12. According to the investigator's judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs); 13. Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-week PFS%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;CA125 response rate;Clinical benefit rate;Duration of Remission;Quality of life;Safety Profile;Blood; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center
Outcome results
None listed