This is a single arm, open label, single center, and prospective, interventional study to explore clinical efficacy of afatinib in patients with chordoma of skull base. Subject meeting the inclusion criteria will take afatinib (40 mg daily) orally, 4 weeks for a cycle. The primary objective is to assess the efficacy of afatinib in chordoma of skull base by objective response rate (ORR). The Secondary objectives is to assess progression free survival (PFS), overall survival (OS), tumor response duration and tumor shrinkage degree in patients with chordoma of skull base after using afatinib; to evaluate the safety and tolerability of afatinib in patients with chordoma of skull base.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will receive evaluations at the beginning of treatment, after every three cycles and at the end of the whole study.
Huashan Hospital
Shanghai, Shanghai Municipality, China
Objective response rate
Proportion of patients with reduction in tumor volume to a predefined value for a minimum period. Generally, ORR is defined as the sum of complete response and partial response. The best response, that is, the best response throughout the study, will be evaluated.
Time frame: 12 months after enrollment
Progression-free survival
duration from the date of inclusion until the date of objective tumor progression or death.
Time frame: 12 months after enrollment
Overall survival
duration from the date of inclusion until the date of death.
Time frame: 12 months after enrollment
Duration of response
duration of partial response and complete response, that is, duration from effective date to the date of proved tumor progression.
Time frame: 12 months after enrollment
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