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The study is a prospective, single-arm, open label, exploratory phase 2 clinical trial, which aims to study the therapeutic effect of letrozole combined with anlotinib hydrochloride in platinum-resistant recurrent ovarian cancer.
The study is a prospective, single-arm, open label, exploratory phase 2 clinical trial, which aims to study the therapeutic effect of letrozole combined with anlotinib hydrochloride in platinum-resistant recurrent ovarian cancer.The patient has undergone surgery and received ≥2 lines of platinum-containing chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole combined with anlotinib hydrochloride | Experimental | Letrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole combined with anlotinib hydrochloride | Drug | Letrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival time | 3 years and 5 years |
| OS | Overall survival | 3 years and 5 years |
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Inclusion Criteria:
1) Adequate bone marrow function at screening: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil ≥1.5×109/L; Platelets ≥80×109/L; 2) Biochemical test: Total bilirubin≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT or AST ≤ 5×ULN; Serum creatinine ≤ 1.5×ULN or endogenous creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula); 9. The patient has not been treated with other tyrosine kinase inhibitor (TKI) drugs; 10. The patient has not received tumor endocrine therapy; 11. Patients should have good compliance and the family members agree to cooperate in the survival follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xipeng Wang, Doctor | Contact | 86-021-25078999 | wangxipeng@xinhuamed.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41166983 | Derived | Wang Y, Li J, Yang Y, Lu X, Xu H, Zhao S, Guan W, Wang X. Letrozole plus anlotinib as a chemotherapy-free regimen for ER-positive platinum-resistant recurrent epithelial ovarian cancer patients following second-line platinum-based chemotherapy failure: A prospective, single-arm, open-label, phase II study. Gynecol Oncol. 2025 Dec;203:67-74. doi: 10.1016/j.ygyno.2025.10.023. Epub 2025 Oct 29. |
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| AE | Adverse event | 3 years and 5 years |