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To explore the curative effect of Corbrin Capsule and influencing factors of proteinuria caused by Apatinib: A prospective randomized controlled study

To explore the curative effect of Corbrin Capsule and influencing factors of proteinuria caused by Apatinib: A prospective randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014662
Enrollment
Unknown
Registered
2018-01-27
Start date
2016-12-20
Completion date
Unknown
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

research group:Oral Bailing Capsule

Sponsors

Nanyang Central Hospital, He'nan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) age 18-75, male and female; 2) the ECOG score less than 3 points, life expectancy greater than 3 months; 3) patients who had previously received at least one chemotherapy regimen that could not be tolerated or failed to recur; 4) drug therapy without the molecular target of antivascular survival. If you have received chemotherapy, radiotherapy or surgery, must be over 4 weeks, and the adverse reactions or wound has been completely restored 5) the level of organ function must conform to the following requirements: (1) HB = 90 g/L blood routine examination; (without blood transfusion within 28 days); ANC = 1.5*10^9/L; PLT = 80*10^9/L; (2) ALB = 30g/biochemical tests (not losing ALB within 14 days) of ALT and AST<2.5*ULN (you present liver metastasis ALT and AST<5*ULN); TBIL = 1.5; normal renal function; (3) Doppler ultrasound assessment of left ventricular ejection fraction (LVEF) than low limit of normal (50%); 6. to be able to understand this study and have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) have been confirmed to apatinib and / or its accessories allergy; 2) people with uncontrolled high blood pressure (systolic blood pressure, diastolic blood pressure >140 mmHg, >90 mmHg, despite the best drug treatment), with grade II above myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 MS); according to the standard of NYHA, III ~ heart grade is not complete, or echocardiography showed that left ventricular ejection fraction (LVEF 1.5, APTT>1.5 ULN), with bleeding tendency; 5) a variety of factors that affect the absorption of oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 6) pregnant or lactating women; 7) patients with acute or chronic renal disease (including renal cancer); 8) patients with a history of psychotropic drug abuse and incapable of abstinence or mental disorders; 9) patients who had participated in other clinical trials within 4 weeks; 10) VEGFR inhibitors, such as Sola Fini and suneinib, were treated. 11) according to the researchers' judgment, there is a serious damage to the patient's safety or the patient who has affected the patient's study with the disease; 12) researchers recognize that it is not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
the incidence of proteinuria;

Secondary

MeasureTime frame
Drug safety;Quality of life;Objective response rate;Disease Control Rate;VEGF;cytokine;

Countries

China

Contacts

Public ContactQu zhongyu

Nanyang Central Hospital of Henan

sunnyday224@126.com+86 0377-63200088

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026