Clinical study of Anlotinib as Third-Line or Further Treatment on Advanced Epithelial Ovarian Cancer
- Conditions
- epithelial ovarian cancer
- Registration Number
- ITMCTR1900002442
- Lead Sponsor
- Oncology Department, Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Aged 18-75 years;
(2) Epithelial ovarian cancer was diagnosed by pathology or cytology.
(3) The stage of diagnosis is stage IV or after the previous radical treatment, recurrence and metastasis are re-staged to stage IV;
(4) After the first-line and second-line treatmentthe tumor progresses again;
(5) Behavioral status PS (ECOG) 0-2;
(6) The estimated survival time is greater than 3 months;
(7) Normal function of bone marrow, liver and kidney:
Hb (hemoglobin) >= 80g / L;
NEUT (neutrophil count) >= 1.5*10^9 / L;
PLT (platelet) >= 90*10^9 / L;
Alanine aminotransferase (ALT)<= 2.5*upper limit of normal(ULN) (if combined with liver metastasis, ALT <= 5* ULN);
Total bilirubin (TB) <= 1.5 * ULN;
Protein (ALB) >= 30g / L;
Creatinine (Scr) <= 1.5 * ULN;
(8) Knowing to participate in the study, sign the informed consent, good compliance and can follow-up;
(9) Women in childbearing age were negative for pregnancy test (blood/urine hCG) within 7 days. And ensured effective contraception during the trial and within 6 months after the end of the trial.
(1) Combined with hypertension and poor drug control, the blood pressure after standard antihypertensive treatment is higher than 140/90mmHg;
(2) Combined bleeding risk;
(3) Concomitant merger of other malignant tumors within five years;
(4) Those who combine active tuberculosis and other serious infectious diseases;
(5) Patients who have received radiotherapy;
(6) Has received other anti-angiogenic drugs;
(7) There are serious brain diseases or mental illnesses that affect the patient's ability to complain privately;
(8) With the history of organ transplantation;
(9) Participated in other clinical studies within 4 weeks;
(10) Pregnant or lactating women.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival;
- Secondary Outcome Measures
Name Time Method Overall Survival;side effects;