HER2-positive or mutant solid tumors
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HER2 positive or mutant solid tumors confirmed by pathological examination: HER2 positive is defined as >10% immunohistochemical (IHC) score of immunoreactive cells of 3+ or in situ hybridization (ISH) results as HER2 gene amplification; 2. HER2 mutation. Need to receive pyrrotinib maleate tablets drug treatment (single drug, or combination therapy can be)
Exclusion criteria
Exclusion criteria: Those who have one of the following conditions are not selected as subjects: 1. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the administration and absorption of drugs. 2. A history of immunodeficiency, including a positive HIV test, HCV, active hepatitis B or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 3. Have had any heart disease, including: (1) Arrhythmia requiring medical treatment or clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease judged by the investigator as unsuitable for participating in this trial. 4. Female patients during pregnancy and lactation, female patients who are fertile and have a positive baseline pregnancy test. 5. A clear history of neurological or mental disorders, including epilepsy or dementia. The researcher believes that the patient is not suitable to participate in any other situations in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;Survival rate without invasive tumor recurrence;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactZhong Jin-Cai
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed