Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced Unresectable or Metastatic Chordoma

  • STATUS
    Recruiting
  • days left to enroll
    67
  • participants needed
    60
  • sponsor
    Peking University People's Hospital
Updated on 23 January 2021
ct scan
imatinib
tyrosine
KIT
EGFR
anlotinib
PDGFRA
sarcoma
metastatic chordoma

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 inhibitors targeted at the stem cell factor receptor (KIT) and the platelet-derived growth factor receptors (PDGFRA and PDGFRB), eg. imatinib. Anlotinib is a novel tyrosine kinase inhibitor targeting both at VEGFR-2, -3 and PDGFRA and PDGFRB with high affinity, which also showed broad antitumor activity against EGFR and so on. Thus this multicenter, two-armed phase II trial of PKUPH-sarcoma 05 intended to investigate the efficacy and safety of anlotinib versus imatinib on advanced chordoma.

Details
Condition Drug effect, Quality of life, Germ cell tumor, Chordoma, Advanced Cancer, Germ Cell Tumors, cancer advanced, quality-of-life
Treatment Anlotinib Hydrochloride
Clinical Study IdentifierNCT04042597
SponsorPeking University People's Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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