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Results failed to achieve the anticipated effect.
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This multicenter, open-label, prospective cohort clinical study enrolled 70 patients with late-stage ER(+)platinum-sensitive recurrent ovarian cancer who had achieved CR/PR after first-line PARP inhibitor maintenance therapy. The study was divided into two cohorts, with 35 participants in each. Cohort 1 (triple-drug group) received the following treatments: Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Fluzoparib: 100 mg orally twice daily, with a 4-week continuous treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle.
Cohort 2 (dual-drug group) received: Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle. reatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (triple-drug group) | Experimental | Patients with advanced, estrogen receptor-positive, platinum-sensitive recurrent ovarian cancer who had previously received first-line poly (ADP-ribose) polymerase (PARP) inhibitor maintenance therapy. |
|
| Cohort 2 (dual-drug group) | Experimental | Patients with advanced, estrogen receptor-positive, platinum-sensitive recurrent ovarian cancer who had previously received first-line poly (ADP-ribose) polymerase (PARP) inhibitor maintenance therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1 (triple-drug group) | Drug | Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Fluzoparib: 100 mg orally twice daily, with a 4-week continuous treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle. Treatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month progression-free survival rate | The proportion of patients who survive without disease progression (defined as any increase in tumor size or death from any cause) within 6 months from the start of the formal treatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Defined as the time from the start of formal treatment to the occurrence of disease progression (in any aspect) or death from any cause. | 12 months |
| Overall Survival (OS) |
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Inclusion Criteria:
Hematological tests (no blood transfusion or use of hematopoietic growth factors within 7 days prior to screening):
Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L; White blood cell count (WBC) ≥ 3.0×10⁹/L and ≤ 15×10⁹/L;
Biochemical tests (no blood transfusion or albumin within 7 days prior to screening):
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); Alkaline phosphatase (ALP) ≤ 2.5 ULN; Total bilirubin (TBIL) ≤ 1.5 ULN; Serum creatinine (Cr) ≤ 1.5 ULN, with creatinine clearance (CrCL) ≥ 60 mL/min (Cockcroft-Gault formula); Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN, with international normalized ratio (INR) ≤ 1.5 ULN (not receiving anticoagulant therapy); Urinalysis: Urine protein < 2+; if urine protein ≥ 2+, then 24-hour urine protein quantification must show protein ≤ 1 g; 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) for females < 470 ms;
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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|
| Cohort 2 (dual-drug group) | Drug | Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle. Treatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred. |
|
Defined as the time from the start of formal treatment to death from any cause, calculated in the intention-to-treat (ITT) population.
| 24 moths |
| Time to First Subsequent Anti-Cancer Treatment (TFST) | The time from the start of formal treatment in the study to the initiation of the first subsequent anti-cancer treatment. | 12 months |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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