Ovarian Cancer, Tubal Cancer and Peritoneal Cancer
Conditions
Interventions
single arm:Apatinib combined with Etoposide
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients who sign an informed consent form and are willing to complete the study according to the plan. 2) Patients with eighteen to seventy years. 3) Patients with ovarian, fallopian tube and peritoneal cancer diagnosed by pathological histology clearly. 4) Patients who have previously received at least one platinum-containing chemotherapy to achieve clinical complete remission of CR and relapse six months after chemotherapy is completed; After relapse, it is not suitable for re-operation for all kinds of reasons. 5) Clear biochemical recurrence (GCIG standard) CA125 have increased more than twice the maximum value or imaging clear diagnosis of recurrence (the total length and diameter of the original target lesions have increased by more than twenty percent or new lesions have disappeared) and distant metastasis (CT/MRI/PET-CT). 6) The patient's ECOG physical state score is 0 or 1. 7) Patients who have ability to comply with the plan. 8) Expected survival time is more than or equal to twelve weeks. 9) Good organ function, including: A. Neutrophil count is more than or equal to one thousand, five hundred every microliter. B. Platelets is more than or equal to one hundred thousand every microliter. C. Hemoglobin is more than or equal to ninety grams every litre. D. Serum creatinine is less than or equal to one point five times the upper limit of normal value or creatinine clearance is more than or equal to sixty milliliter every minute. E Total bilirubin is less than or equal to one point five times the upper limit of normal value or direct bilirubin is less than or equal to one times the upper limit of normal value. F.AST and ALT is less than or equal to two point five times the upper limit of normal value. Liver metastasis must be less than or equal to five times the upper limit of normal value. G. Serum albumin is more than or equal to thirty grams every liter. 10) The pregnancy test results at the time of admission were negative and women of childbearing age who have promised to take contraceptive measures fully and effectively from the beginning of the study to the end of the study and within three months after the last administration of study medication or Abstinency could be enrolled in the study, or the women enrolled in the study are women with no potential fertility, defined as: A. Women undergoing surgical sterilization (hysterectomy, bilateral Ovariectomy or bilateral salpingectomy). B. Women are more than or equal to sixty years old. C. Women are more than or equal to forty years old and less than or equal to sixty years old and menopause for more than twelve months. And follicle stimulating hormone test results are within the reference range of research institutions after menopause. 11) The toxic and side effects of any previous chemotherapy have recovered to less than or equal to CT CAE level one or baseline level, except sensory neuropathy or alopecia with less than or equal to CT CAE level two stable symptoms.
Exclusion criteria
Exclusion criteria: 1) Known allergy to active or inactive components of apatinib, etoposide or two drugs with similar chemical structures of the drugs. 2) Previous treatment with VEGFR2 inhibitor. 3) Ascites drainage is performed in the last two chemotherapy Period of the last first-line chemotherapy scheme before entering the group. 4) Symptomatic and uncontrolled brain metastasis or leptomeningeal metastasis. No imaging scan is needed to confirm that there is no brain metastasis. Patients with spinal cord compression may still be considered for inclusion if they have received targeted treatment and have evidence of clinical stability of the disease for at least more than twenty-eight days (controlled central nervous system metastasis must have received treatment such as radiotherapy or chemotherapy at least one month before entering the study; Patients must not have new symptoms related to central nervous system lesions or symptoms indicating disease progression. And patients either take a stable dose of hormone or do not need to take hormone). 5) Patients have undergone major surgery three weeks before the study. Or any surgical effects that have not been recovered after the previous surgery persisted. 6) Patients who have received palliative radiotherapy of more than twenty percent bone marrow before admission. 7) Suffering from invasive cancer other than ovarian cancer within two years before joining the group. 8) The patient has previously or currently diagnosed MDS or AML. 9) Suffering from serious or uncontrollable diseases, including but not limited to: A. Uncontrolled nausea and vomiting, inability to swallow study drugs and any gastrointestinal diseases that may interfere with drug absorption and metabolism. B. Active viral infections, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc. C. Uncontrolled ventricular arrhythmias with myocardial infarction in the last three months. D. Uncontrolled grand mal seizure, unstable spinal cord compression, superior vena cava syndrome or other gastrointestinal diseases affecting drug absorption and metabolism E Immune deficiency (except splenectomy) or other diseases where researchers may be exposed to high-risk viruses. 10) Any previous or current diseases, treatments, or laboratory abnormalities that may interfere with the results of the study and affect the patient's participation in the whole study. Or the researcher believes that the patient is not suitable to take part in the study; Patients are not allowed to receive platelet and red blood cell transfusion in the four weeks before the study drug treatment. 11) Patients who are pregnant or nursing, or are expected to plan pregnancy during the study treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS;TTP;PFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1;pelvic CT/MRI; | — |
Countries
China
Contacts
Public ContactXi Cheng
Fudan University Shanghai Cancer Center
Outcome results
None listed