Status:
UNKNOWN
Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Peking University Shougang Hospital
Peking University Third Hospital
Conditions:
Effect of Drugs
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
For local relapse not amenable to reasonable curative surgery or for those with metastatic chordoma, chemotherapy is recognised as inactive. The major study drug is the small molecular tyrosine kinase...
Eligibility Criteria
Inclusion
- 18 years and older;
- histologically proven metastatic or locally advanced chordoma, reviewed by the Pathology Committee of Peking University People's Hospital;
- not amenable to curative-intent surgery;
- measurable with computed tomography scan or magnetic resonance imaging, per RECIST, version 1.1.
Exclusion
- Eastern Cooperative Oncology Group (ECOG)30 performance status more than 2 ;
- life expectancy less than 12 weeks;
- with severe or uncontrolled medical disorders (≥grade 2 of Common Terminology Criteria for Adverse Events version 4.03 \[CTCAE version 4.03\]) that could jeopardise the outcomes of the study, for example, cardiac clinical symptom or disease with LVEF (left ventricular ejection fraction) \<50%, hypertension that could not be well controlled through antihypertensive drugs and so on;
- weight loss of 20% or more before illness;
- brain or leptomeningeal metastasis;
- surgical procedure or radiotherapy within 4 weeks of enrollment;
- active gastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
- proteinuria or hematuria;
- denutrition with albuminemia less than 25 g/L;
- pregnant or breastfeeding status;
- other malignancy, positive HBV/HCV/HIV serology;
- known allergy to the experimental agents;
- had ever used anti-angiogenesis TKIs.
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04042597
Start Date
July 18 2019
End Date
December 31 2021
Last Update
August 5 2019
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044