A single arm, open-label Phase II clinical study.The subjects were patients with lung, gastric and colorectal cancers.
Object: 1.The main purpose: T To observe and evaluate the efficacy of pyrotinib in patients with HER2-mutated/amplified metastatic solid tumors after failure of standard therapy; 2. Secondary objectives: To observe and evaluate the safety of pyrotinib in patients in HER2 mutated or amplified metastatic solid tumors after failure of standard treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Pyrotinib ± standard regimen Pyrotinib: 400 mg/day (once a day, orally at the same time every day), continued until disease progression;
standard regimen
Objective response rate
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
Time frame: 24 months
Overall survival
Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Time frame: 24 months
Disease control rate
the proportion of patients whose tumors shrink or remain stable for a certain period of time, including complete remission (CR), partial remission (PR) and stable (SD) cases
Time frame: 24 months
Progression-free survival
Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.
Time frame: 24 months
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