Ovarian cancer
Conditions
Interventions
1:amlotinib for one year
2:Placebo for one year
3:amlotinib+chemotherapy 6 cycles
4:Placebo + chemotherapy 6 cycles
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) ovarian cancer diagnosis standard: 1) biopsy proven (serous cancer, endometrial carcinoma, or mixed) 2) for clinical stage II - IV (FIGO, 2014); (2) always shrink tumor surgery or (and) first-line chemotherapy clinical evaluation after complete remission (CR), failure (including partial response, stability, or progress) and platinum resistance type relapses; (3) aged 18 to 70 years; (4) the ECOG: 0-1; (5) estimated survival time is more than 3 months; (6) into the group must be completed within 14 days before history; (7) into the group conducted within 30 days before the chest CT, full abdomen enhanced CT or PET/CT examination within 30 days before; (8) into the group had pelvic enhanced CT, MRI and PET/CT examination; (9) laboratory tests needs to be done within 14 days before the group, the bone marrow, liver and kidney function test; (10) gestational age women must agree to take effective contraceptive measures during treatment research; (11) into the group of patients' informed consent must be signed before the study get started.
Exclusion criteria
Exclusion criteria: (1) carcinosarcoma, clear cell carcinoma, mucous adenocarcinoma borderline epithelial tumors, and low level (level 1) carcinoma and malignant sex cord stromal/germ cell tumors; (2) for phase I clinical stage of ovarian epithelial carcinoma; (3) the sick since pot belly had radiotherapy; (4) in recent 3 years had other systemic chemotherapy or targeted therapy; (5) pregnant women or nursing mothers concurrent disease; (6) has the following serious activity: in the past six months have unstable angina and/or congestive heart failure requiring hospital treatment; In the last 6 months there have been transmural myocardial infarction; Have had cerebral infarction and have symptoms in the last 6 months; Acute bacterial or fungal sensation requiring intravenous antibiotic treatment at the time of registration; Chronic obstructive pulmonary disease progression or other respiratory diseases requiring hospitalization or obstructing research; Poor liver function leads to jaundice or coagulation dysfunction, or renal failure; Acquired immunodeficiency disease (refusal to test for HIV in patients who have been diagnosed with AIDS or who are suspected to have AIDS); Other immunodeficiency conditions (such as organ transplantation, long-term use of glucocorticoid, etc.); Others: gastrointestinal perforation, wounds requiring clinical treatment, marked bleeding tendency, nephrotic syndrome or hypertensive crisis;In addition, patients with clinically not diagnosed moderate to severe proteinuria, uncontrolled hypertension (>140/90mmhg) and patients with thrombosis receiving anticoagulation therapy are still to be confirmed
Countries
China
Contacts
Public ContactQinglian Wen
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed