solid tumors
Conditions
Interventions
experimental group:Pyrotinib-based treatment
Sponsors
Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. ECoG PS score: 0-1; 3. Patients with advanced HER2-positve solid tumor; 4. Clinically approved methods (including PCR, FISH, immunohistochemistry and NGS) detect the expression of HER2, and the data obtained by the pathology laboratory of the hospital and the second-generation sequencing (NGS) performed by a qualified genetic testing institution are recognized; 5. The functional level of major organs must meet the following requirements(No blood transfusion, no use of white blood cell or platelet-increasing drugs within 2 weeks before screening): 1)Blood routine: neutrophil count > 1.5 * 10^9 / L; platelet count >= 100 * 10^9 / L; red protein >= 90 g / L; 2) Blood biochemical: total bilirubin = 55%; 6. Voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. The third space effusion (such as large amounts of pleural fluid and ascites) cannot be controlled by drainage or other methods. The efficacy of clinical treatment cannot be evaluated; 2. In the 4 weeks before screening, the patient has received major surgery or significant trauma, or is expected to undergo major surgery; 3. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the administration and absorption of the drug; 4. People with a history of psychotropic drug abuse and unable to quit, or suffering from mental disorders; 5. Pregnant or breast-feeding women; 6. Fertility patients who are unwilling or unable to take effective contraceptive measures; 7. The patient has serious concomitant diseases or the researcher thinks it is not suitable to participate in this research; 8. Previous clinical use of pyrotinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;ORR;OS;DoR; | — |
Countries
China
Contacts
Public ContactQian Jun
Jiangsu Province Hospital of Chinese Medicine
Outcome results
None listed