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A single-arm, single-center, open-label clinical study of apatinib in the treatment of metastatic renal cell carcinoma

A single-arm, single-center, open-label clinical study of apatinib in the treatment of metastatic renal cell carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015718
Enrollment
Unknown
Registered
2018-04-16
Start date
2018-04-30
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Renal cell carcinoma

Interventions

Case series:apatinib

Sponsors

The Cancer Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years male and female; 2. Renal cell carcinoma patients confirmed by pathologically; 3. ECOG 0-2;4.Estimated survival time=3 mouths; 4. Estimated survival time=3 mouths; 5. Confirmed by pathology with measurable lesions, (CT scan Long diameter of tumor=10mm, CT scan Long diameter of lymph node lesion=15mm, scan slice thickness>5mm); 6. The main organ function is normal, and meet the following standards: (1) The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=80×10^9/L; (2) Biochemical tests should meet the following criteria: BIL45ml/min. 7. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 8. Patients voluntarily entered the study and signed informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg, diastolic pressure >90mmHg); 3. Variety of factors affecting oral drugs (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 4. Coagulopathy (INR>1.5×ULN APTT>1.5×ULN), with Bleeding tendency; 5. Urinary protein is more than + + and confirmed the 24 hour urinary protein quantitative>1g; 6. Received apatinib or other VEGFR inhibitors, such as bevacizumab, Solafinib, Sunitinib; 7. Metastases of the central nervous system with symptoms; 8. Other cases the researchers judged that could affect the outcome of the clinical study.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactChen Hui

The Cancer Hospital of Harbin Medical University

834287905@qq.com+86 13603612355

Outcome results

None listed

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