epithelial ovarian cancer
Conditions
Interventions
Experimental Group:Apatinib (175 mg, qd) orally
Control Group:NA
Sponsors
Hu'nan Previncial Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 73 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 73 years. 2. Women with newly diagnosed and histologically proven high-risk advanced (FIGO III-IV) epithelial ovarian cancer, primary peritoneal cancer and/or fallopian tube cancer who have completed first-line platinum-containing chemotherapy (intravenous or intraperitoneal administration) have achieved clinical CR/PR. 3. Phase III patients must have undergone an optimal tumour reduction (pre-or septal tumour reduction); phase IV patients must undergo biopsy and/or pre-or septal tumour reduction. 4. Patients who had completed first-line platinum-containing chemotherapy (such as carboplatin or cisplatin or other platinum) prior to randomization (intravenous or intraperitoneal administration): (1) After the completion of the chemotherapy, the researchers judged that after the treatment, imaging examination showed complete or partial clinical remission without disease progression or elevated CA-125 level. After completing the first-line platinum-containing chemotherapy, imaging examination after treatment showed that patients with stable condition did not qualify for the study. (2) The "response" used in the whole research program refers to the judgement of the researcher that the patient had complete or partial clinical remission according to the image examination after treatment. Clinical complete remission is defined as no evidence of measurable or non-measurable diseases in RECIST 1.1 and normal CA-125 levels after treatment. Partial remission is defined as the reduction of tumor volume by more than 30% or the absence of evidence of measurable disease in RECIST 1.1 from the beginning to the end of chemotherapy and the absence of CA-125 levels within the normal range according to imaging findings after treatment. (3) The platinum-containing chemotherapy course includes at least six treatment cycles and at most nine treatment cycles. However, if platinum-containing chemotherapy must be discontinued due to toxic reactions caused by platinum therapy, the patient must have received at least four platinum treatment cycles. (4) Patients must be randomly divided into groups within 8 weeks of the last chemotherapy (the last administration is the day of the last infusion). 5. The detection results of CA-125 before treatment must meet the following specific criteria: (1) If the first detection value is less than or equal to the upper limit of normal value (ULN), patients can be randomly grouped without the need for a second sampling. (2) If the first detection value is greater than ULN, a second evaluation must be made at least 7 days after the first detection. If the second evaluation value of patients is higher than or equal to 15% of the first evaluation value, the patients will not be eligible for admission. 6. Organ and bone marrow function must be normal within 28 days prior to the study of treatment, defined as follows: (1) No blood transfusion was received within 28 days and hemoglobin (> 10.0 g/dL); (2) Absolute neutrophil count (ANC) > 1.5 x 10^9/L; (3) Platelet count (> 100X10 ^ 9/L); (4) The upper limit of normal value (ULN) of total bilirubin < 1.5 times; (5) Aspartate aminotransferase (AST) (serum glutamic oxalate aminotransferase (SGOT) / alanine aminotransferase (ALT) (serum glutamic alanine aminotransferase (SGPT) = 2.5 times the upper limit of normal value, if there is liver metastasis, it should be less than 5 times ULN; (6) Serum creatinine < 1.5 times ULN. 7. No active bleeding, ulcer, intesti
Exclusion criteria
Exclusion criteria: 1. Images of patients after treatment showed stable condition or disease progression, or clinical evidence of disease progression at the end of first-line chemotherapy. 2. Allergic to any component of Apatinib Mesylate. 3. Other malignant tumors have occurred in the past five years, except for adequately treated non-melanoma skin cancer, effectively treated cervical cancer in situ, stage I ductal carcinoma in situ (DCIS), stage I endometrial cancer, or other solid tumors, including lymphomas that have been effectively treated and have no evidence of disease for more than five years (not involving bone marrow). Patients with a history of local breast cancer may be eligible for inclusion, provided that adjuvant chemotherapy has been completed for more than three years before enrollment and that patients have no recurrent or metastatic diseases. 4. Resting electrocardiogram (ECG) QTc > 470 milliseconds or family history of long QT syndrome at 2 or more time points within 24 hours. 5. Accept any systemic chemotherapy or radiotherapy (except for palliative reasons) within three weeks (or longer, depending on the characteristics of the drug used) prior to the study. 6. Previous cancer treatment resulted in persistent toxicity (> CTCAE), excluding hair loss. 7. Patients with myelodysplastic syndrome/acute myeloid leukemia. 8. If a major operation is performed within two weeks before the start of the study, the patient must have recovered from the impact of the major operation. 9. Because of serious and uncontrollable medical diseases, patients with non-malignant systemic diseases or active and uncontrollable infections have greater medical risks. Examples include, but are not limited to, uncontrolled ventricular arrhythmias, recent (3-month) myocardial infarction, uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial disease of the lungs as shown by high-resolution computed tomography (HRCT), or any psychiatric disorder that leads to the failure to sign informed consent. 10. Patients who are unable to swallow oral preparations and gastrointestinal dysfunction may interfere with the absorption of research drugs. 11. Lactating women. 12. Patients with low immune function, such as those with positive serum response to human immunodeficiency virus (HIV). 13. Patients are known to have hypersensitivity to apatinib or its excipients. 14. Patients with known active hepatitis (i.e. hepatitis B or C), such as patients with HBsAg +, HBV DNA < 1*104copies/ml (2000IU/ml), can still be studied, and they are at risk of infection transmitted by blood or other body fluids. 15. Previous bone marrow allotransplantation. 16. Full blood transfusions were received within 120 days before the start of the study. 17. Uncontrolled hypertension, grade 3-4 cardiac insufficiency (NYHA standard), and severe hepatorenal insufficiency (grade 4). 18. Researchers judge other situations that may affect the conduct of clinical research and the outcome of research.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Quality of life score QoL;Exploratory molecular markers; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Countries
China
Contacts
Public ContactJie Tang
Hu'nan Previncial Cancer Hospital
Outcome results
None listed