A Study of Apatinib Treatment in for Advanced Ovarian Cancer
Primary Purpose
Ovarian Cancer, Chemotherapeutic Toxicity
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Taxus + platinum
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer
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.
Sites / Locations
- Zhang xuanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
apatinib combine with chemotherapy
chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
PFS(Progress free survival)
he length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
carcinoma antigen 125 (CA125)
Cancer antigen 125 (CA-125) is a protein found on the surface of many ovarian cancer cells. It also can be found in other cancers and in small amounts in normal tissue. A CA-125 test measures the amount of this protein in the blood.
Secondary Outcome Measures
Full Information
NCT ID
NCT03393507
First Posted
January 2, 2018
Last Updated
January 11, 2018
Sponsor
The People's Hospital of Leshan
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03393507
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The People's Hospital of Leshan
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Chemotherapeutic Toxicity
Keywords
ovarian cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
apatinib combine with chemotherapy
Arm Type
Experimental
Arm Title
chemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
500mg,po, adjusted to 250mg if cannot tolerate, 3 weeks a cycle for a total of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Taxus + platinum
Intervention Description
Taxanes are paclitaxel or docetaxel, and platinum is carboplatin or cisplatin. Docetaxel injection dose size of 60-75mg / m2, infusion time of 1 hour; paclitaxel injection dose size 135-175mg / m2, infusion time> 3 hours; injection of carboplatin dose according to the standard formula Calculated, AUC = 4-5, continued intravenous infusion the next day; cisplatin injection dose size of 75-100mg / m2.
Primary Outcome Measure Information:
Title
PFS(Progress free survival)
Description
he length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Time Frame
24 month
Title
carcinoma antigen 125 (CA125)
Description
Cancer antigen 125 (CA-125) is a protein found on the surface of many ovarian cancer cells. It also can be found in other cancers and in small amounts in normal tissue. A CA-125 test measures the amount of this protein in the blood.
Time Frame
24month
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only female can be enrolled
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Zhang, MDB
Phone
8618990631232
Email
79916363@qq.com
Facility Information:
Facility Name
Zhang xuan
City
Leshan
State/Province
Sichuan
ZIP/Postal Code
600000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Xuan, MD
Phone
861890631232
Email
79916363@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of Apatinib Treatment in for Advanced Ovarian Cancer
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