Clinical trial NCT03393507: A Study of Apatinib Treatment in for Advanced Ovarian Cancer
Official title: A Study of Apatinib in Combination With Chemotherapy Versus Chemotherapy Alone for Advanced Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Chemotherapeutic Toxicity
Keywords: ovarian cancer
Lead sponsor: The People's Hospital of Leshan
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2018-01-08
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is evaluated the effacy and safety of apatinib combined with chemotherapy in the advanced ovarian cancer

Detailed description: Ovarian cancer and fallopian tube cancer are common gynecological malignancies in our country. Ovarian cancer ranks the second in the incidence of gynecologic malignancies. The mortality rate is the highest. The following three major characteristics exist: First, 70% of the patients are advanced patients; 70% of the patients Easy to relapse after treatment; Third, 5-year survival rate of about 30%, a serious threat to women's health. Our hospital ovarian cancer, tubal cancer patients because of regional constraints, the economy is poor, the more the past, the use of simple chemotherapy, relapse rate and mortality were higher.

In the latest National Comprehensive Cancer Network (NCCN) guidelines, bevacizumab plus CP is recommended for patients with stage II, III, and IV ovarian cancer and fallopian tube cancer, and clinical trials of new drugs are recommended for recurrent / metastatic ovarian cancer. Apatinib mesylate is a small molecule VEGFR tyrosine kinase inhibitor authored by Jiangsu Hengrui Pharmaceutical Co., Ltd., whose chemical name is N- \[4- (Cyanocyclopentyl) phenylmethane sulfonate \] \[2 - \[(4-picolyl) amino\] (3-pyridyl)\] carboxamide of the formula C25H27N5O3S with a molecular weight of 493.58 (mesylate salt).Apatinib can effectively inhibit VEGFR-2 at a very low concentration, while higher concentrations can inhibit the action of apatinib, such as platelet-derived growth factor receptor (PDGFR), c-Kit and c- The site is the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamic studies show that apatinib can inhibit the VEGFR-2 tyrosine kinase activity, blocking VEGF signaling after binding, resulting in inhibition of tumor angiogenesis. Preclinical studies have shown that apatinib has a strong inhibitory effect on the growth of many human nude mice xenografts such as sarcoma, colorectal cancer, non-small cell lung cancer, gastric cancer and liver cancer and is a broad-spectrum anti-tumor drug.

Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, stage II-IV period, the expected survival of\> 6 months;
* ECOG \<2;
* Liver and kidney function is normal;
* No uncontrollable high blood pressure, bleeding, perforation, obstruction.

Exclusion Criteria:

* Serious cardiopulmonary insufficiency, can not tolerate chemotherapy;
* Pregnant or lactating women;
* 3 years have occurred in other tumors (cervical cancer in situ, has cured basal cell carcinoma, except for bladder epithelial tumors);
* Allergic to apatinib or its accessories.

Primary outcomes:
measure: PFS(Progress free survival)
timeFrame: 24 month
measure: carcinoma antigen 125 (CA125)
timeFrame: 24month
Secondary outcomes:
Other outcomes:
Locations:
city: Leshan
country: China
facility: Zhang xuan
state: Sichuan
Study officials:
References: