Ovarian cancer
Conditions
Interventions
Trial Group:Dalpiciclib:
In combination with letrozole + apatinib: 100 mg once daily, taken at approximately the same time each day, with food avoided 1 hour before and 1 hour after dosing. Administer
the next scheduled dose should be taken as planned.
Apatinib: 250 mg once daily, orally, taken 30 minutes after a meal at approximately the same time each day (28 days per treatment cycle).
Letrozole:
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 3. Patients with histologically or cytologically confirmed recurrent or metastatic ovarian cancer, including low-grade serous carcinoma, endometrioid carcinoma, or platinum-resistant high-grade serous carcinoma, with at least one measurable lesion according to RECIST version 1.1; 4. Received at least one prior platinum-based chemotherapy regimen and experienced disease recurrence or progression after treatment. For high-grade serous carcinoma, platinum resistance is required, defined as disease progression within 6 months after the last platinum-based chemotherapy. Prior anti-angiogenic therapy (e.g., bevacizumab) is permitted but must be discontinued for >= 4 weeks. No prior treatment with CDK4/6 inhibitors; 5. Estrogen receptor (ER) positivity is defined as the proportion of positively stained tumor cells >= 1% of all tumor cells; 6. Expected life expectancy >= 6 months; 7. Adequate major organ function, with the following laboratory results obtained within 7 days prior to enrollment: (1) Hematology (without blood transfusion or hematopoietic growth factor support within 7 days before screening): 1) Hemoglobin (Hb) >= 90 g/L; 2) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Absolute lymphocyte count (LC) >= 0.5 × 10^9/L; 3) Platelet count (PLT) >= 100 × 10^9/L; 4) White blood cell count (WBC) >= 3.0 × 10^9/L and = 60 mL/min (by Cockcroft-Gault formula); 5) Prothrombin time (PT) and activated partial thromboplastin time (APTT) = 2+, then 24-hour urine protein quantification must be <=1 g; (4) 12-lead electrocardiogram: Fridericia’s corrected QT interval (QTcF) < 470 ms in females. 8. Voluntarily participate in this study, sign the informed consent form, have good compliance, and be able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any component of the investigational product or its excipients; 2. Active brain metastases; 3. Receipt of systemic treatment with Chinese herbal medicines having anti tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first dose; 4. Presence of severe cardiovascular diseases: myocardial ischemia or myocardial infarction grade II or above, poorly controlled arrhythmias (including QTc interval >= 470 ms); New York Heart Association (NYHA) class III IV cardiac dysfunction, or left ventricular ejection fraction (LVEF) 38.5°C during screening or prior to the first dose; or major surgery within 3 weeks prior to the first dose; 6. Type I diabetes mellitus that is not controlled despite an insulin regimen (note: patients with type I diabetes controlled by insulin are excluded from this study); 7. Poorly controlled asthma despite systemic treatment including bronchodilators (note: patients with complete resolution of asthma during childhood and no need for any intervention as adults are not excluded on the basis of asthma alone); 8. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); untreated active hepatitis B; hepatitis C (positive for hepatitis C antibody with HCV RNA above the lower limit of detection of the assay); or co infection with hepatitis B and hepatitis C; 9. Planned or prior solid organ or hematopoietic system transplantation during the study period (except corneal transplantation); 10. Concurrent participation in interventional clinical trial therapy, or receipt of other investigational drugs or investigational devices within 4 weeks prior to the first dose; failure to recover adequately (i.e., = 160 mmHg or diastolic blood pressure >= 110 mmHg despite optimal medical therapy); 12. Coagulation abnormalities (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 × ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; 13. Urinalysis showing urine protein >= ++, or confirmed 24 hour urine protein >=1.0 g; 14. Definite history of allergy, with potential allergy or intolerance to the investigational product or its similar biological agents; 15. History of substance abuse (e.g., psychoactive drugs) that cannot be abstained from, or diagnosis of mental disorder; 16. Hereditary or acquired bleeding disorder or coagulation dysfunction (eligibility to be determined by the investigator); 17. Patients deemed unsuitable for endocrine therapy by the investigator, including those with symptomatic, visceral disseminated disease at risk of life threatening complications in the short term (including uncontrolled massive effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, or liver involvement > 50%); 18. History of cerebrovascular accident or transient ischemic attack within 6 months; 19. Presence of any other serious physical or mental illness or laboratory abnormality that may increase the risk of study p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR;Disease control rate,DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival,PFS;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactShan Ying
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed