Malignant solid tumor of non-breast cancer
Conditions
Interventions
Intervention group:Pyrotinib
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, regardless of gender. 2. Disease progression during the previous standard treatment or disease progression within 6 months after the end of treatment, if the subject develops disease progression after the end of treatment, he still needs to meet the previous systemic treatment for >= 3 cycles; subjects with adenocarcinoma at the gastroesophageal junction requires previous use of trastuzumab, and other tumors must have received at least first-line standard chemotherapy ± targeted therapy. 3. Two or more grade IV hematological toxicity or non-hematological toxicity >= grade III or damage to the heart, liver, kidney and other major organs of grade >= II occurred during the standard treatment process; Patients who have been confirmed by the doctor to no longer receive standard treatment can be included in the group. 4. Pathologically proven gastric and gastroesophageal junction adenocarcinoma, RAS wild-type and BRAF wild-type colorectal adenocarcinoma, esophageal squamous cell carcinoma or adenocarcinoma, and non-breast cancer solid malignant tumors other than the above (Note: RAS Wild type refers to KRAS and NARS exons 2-4 wild type, BRAF wild type refers to BRAF V600E wild type). 5. Cancer tissue pathology is clearly HER2 positive: including IHC2+/ISH+, IHC 3+ or HER2 mutations (the results obtained by NGS method, PCR method, Sanger method, mass spectrometry sequencing and other measurement methods are all acceptable). 6. ECOG score: 0-1 points. 7. For recurrent or metastatic disease, according to the RECIST 1.1 standard, the subject has at least one measurable target disease. 8. Expected survival period >= 12 weeks. 9. Tumor tissue samples must be provided for expression analysis, preferably newly obtained tumor tissues; Subjects who cannot provide newly obtained tissues can provide archived tumor tissue samples; For subjects who have previously received anti-target therapy, they must provide tumor tissue samples after the most recent anti-target treatment, the sample type is formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks, or unstained FFPE tumor tissue sections (not less than 6). 10. The functional level of organs must meet the following requirements: (1) Blood routine: ANC >= 1.5x10^9/L; PLT >= 90x10^9/L; Hb >= 90 g/L; (2) Blood biochemistry: TBIL=50mL/min (Cockcroft-Gault formula); (3) Heart color Doppler ultrasound: LVEF>=50%; (4) 12-lead electrocardiogram: The QT interval (QTcF) corrected by Fridericia's method is <450ms for males and <470ms for females. 11. Have sufficient bone marrow, liver and kidney functions. 12. Women of childbearing age and their spouses are willing to contraception during treatment and within 1 year after the last medication. 13. Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Left ventricular ejection fraction (LVEF) grade 1 unresolved toxicity due to any previous treatment / procedure (ctc-ae, except alopecia, anemia, and hypothyroidism); 6. Severe infection and other serious systemic diseases; 7. Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids or short-term oral steroids are allowed to resist vomiting or promote appetite); 8. Patients with persistent infection > grade 2 (ctc-ae), unhealed wounds, ulcers or fractures, or history of organ transplantation; 9. Evidence or history of coagulation disorders such as bleeding events with grade >= 3 (ctc-ae); 10. Known human immunodeficiency virus (HIV) infection or active hepatitis B and C infection; 11. Intestinal obstruction and other factors affecting oral administration or absorption of drugs; 12. There were still uncorrectable hypokalemia, hyponatremia and hypomagnesemia; 13. The use of drugs that may cause QT prolongation (such as antiarrhythmic drugs) should not be interrupted during the study period; 14. Clinically symptomatic active coronary heart disease, cardiomyopathy or congestive heart failure, New York Heart Association (NYHA) III-IV; uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg), clinically symptomatic heart valve disease, unstable angina pectoris, myocardial infarction or high-risk arrhythmia; 15. After the comprehensive judgment of the disease, the researcher thought that it was not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six weeks objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Security;Progression-free survival; | — |
Countries
China
Contacts
Public ContactLiu Tianshu
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed