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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
anlotinib was given at a fixed dose of 12mg D1-14 every 21 days
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective response rate, ORR
CR+PR in the intent-to-treat population according to RECIST, version 1.1
Time frame: 6 months
Progression-free Survival, PFS
Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation
Time frame: 2 years
Overall Survival, OS
OS is defined as time from randomisation to the first occurrence of death from any cause within 63 days of last response assessment or randomisation.
Time frame: 5 years
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