Ovarian cancer
Conditions
Interventions
Experimental group:anlotinib combined with paclitaxel plus carboplatin
Sponsors
The Second Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed histologically; 2. Patients with platinum-sensitive recurrence are required to have received at least first-line platinum-containing regimens treatment, > 6 months from the last platinum-containing treatment (at least 4 cycles) to the time of disease recurrence and progression and have not received systematic treatment since the recurrence; 3. Aged 18 to 70 years, female; 4. There are objectively measurable lesions according to RECIST 1.0 criteria; 5. ECOG score: 0-2 points; 6. Expected survival >=12 weeks; 7. Signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have had other uncured malignant tumors in the past 5 years or at the same time; 2. Untreated central nervous system metastases; 3. Patients with symptomatic ascites requiring puncture and drainage or those who had received ascites drainage in the past 3 months (except those with non symptomatic ascites of a small amout diagnosed by imaging); 4. Previous gastrointestinal perforation, abdominal abscess or intestinal obstruction within the last 3 months; 5. Hypertension not controlled by drugs (SBP >=140 mmHg or DBP >=90 mmHg); 6. Have not well-controlled cardiac clinical symptoms or diseases, such as: (1) New York Heart Association (NYHA) grade 2 or above heart failure; (2) Unstable angina pectoris; (3) A previous myocardial infarction within 1 year; (4) Atrial fibrillation(clinically significant supraventricular or ventricular arrhythmias require treatment or intervention); (5) PR interphase > 250 ms or QTC > 470 ms; 7. Abnormal coagulation function (INR > 2.0 or prothrombin time [PT] > 16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin and low-molecular weight heparin is allowed); 8. Patients with bleeding symptoms of significant clinical significance or with definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, occurred within 3 months before enrollment; 9. Arterial/venous thrombosis events occurred within the first 6 months of enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc., shallow venous thrombosis could be included after being determined by the investigator; 10. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.); 11. Active ulcers, unhealed wounds or fractures; 12. Urine protein >= ++ by routine urine , and 24-hour urine protein amount > 1.0 g; 13. Previous radiotherapy, chemotherapy or molecular targeted therapy, within 4 weeks after the completion of treatment (no secondary use) and study enrollment (oral molecular targeted drugs less than 5 drug half-life); adverse events caused by previous treatment (except hair loss) did not recover to = 38.5? or white blood cell count > 15 x 10^9/L 7 days before enrollment; 15. Innate or acquired immune deficiency (such as HIV infection); 16. Active hepatitis (HBV reference: HBsAg positive and HBV DNA >= 500 IU/ mL; Hepatitis C reference: HCV antibody positive and HCV virus copy number > upper limit of normal value); 17. For patients with bone metastases, the palliative radiotherapy received within 4 weeks before enrollment was in the > 5% bone marrow area; 18. Still using a strong CYP3A4 inducer or a strong CYP3A4 inhibitor within the first week before enrollment; 19. Previous treatment with amlotinib hydrochloride capsules or other small molecule tyrosine kinase inhibitors; 20. Known allergy to any study drug or excipient; 21. According to the researcher's judgment, patients have other factors that may affect the results of the study or lead to the termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, severe laboratory examination abnormalities, accompanied by family or social factors,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Incidence and severity of adverse events (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Overall survival;Time from enrollment to the first follow-up treatment; | — |
Countries
China
Contacts
Public ContactZhao Hu
The Second Affiliated Hospital of Zhengzhou University
Outcome results
None listed