HER-2 positive colorectal cancer
Conditions
Interventions
HER-2 positive colorectal cancer:pyrroltinib maleate tablets and trastuzumab combined with FOLFOX6 regimen
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly treated patients with age >= 18 years and = 1.5 x 10^9 / L; PLT >= 90 x 10^9 / L; HB >= 90g / L; (2) Biochemical examination should meet the following criteria: TBIL = 50 ml / min (cockcroftgault formula); (3) Echocardiography and echocardiography: left ventricular ejection fraction (LVEF >= 55%); (4) The corrected QT interval (QTCF) of 18 lead ECG was less than 470 MS in women; 5. For women who are not menopausal or have not undergone surgical sterilization: during the treatment period and at least 7 months after the last drug administration in the study treatment, they agree to abstain or use effective contraceptive methods; 6. Patients who voluntarily joined the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with stage IV (metastatic) colorectal cancer; 2. Patients who have received anti-tumor therapy or radiotherapy for any malignant tumor in the past, excluding those with cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 3. Patients who also received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonates therapy or immunotherapy; 4. Patients who have undergone major surgical procedures unrelated to colorectal cancer within 4 weeks before enrollment, or have not fully recovered from such operations; 5. Patients with severe heart disease or discomfort, including but not limited to the following diseases: (1) History of heart failure or systolic dysfunction (LVEF 100 BPM, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular block (i.e., mobitz II second degree atrioventricular block or third degree atrioventricular block) (3) Angina pectoris requiring anti angina drugs (4) Valvular heart disease with clinical significance (5) ECG showed transmural myocardial infarction (6) Poor control of hypertension (systolic blood pressure > 180 mmHg and / or diastolic blood pressure > 100 mmHg) 6. Patients who are unable to swallow, have intestinal obstruction or have other factors affecting drug administration and absorption; 7. Patients who have been known to have allergic history to the drug components of this regimen; have a history of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 8. Pregnant and lactating women, fertile women with positive results of baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study medication; 9. Severe comorbidities or other comorbidities that may interfere with the planned treatment, or any other situation in which the investigator considers the patient unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactZong Hong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed