Digestive Cancer
Conditions
Interventions
Experimental group:Pyrotinib Maleate Tablets
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged >=18 years; 2. Digestive tract tumors diagnosed as HER2 positive by histology or cytology; 3. Definition of HER-2 positivity: IHC3+ or IHC2+ with ISH (or FISH)+ assessed for primary or metastatic tumor lesions (confirmed by investigator review at the trial center). 4. There is no serious liver and kidney function damage, and the functional level of the organs must meet the following requirements: (1) ANC >= 1.5x10^9/L; (2) PLT >= 90x10^9/L; (3) Hb >= 90 g/L; (4) TBIL = 50 mL/min (Cockcroft-Gault formula); (8) LVEF >= 50%; (9) Fridericia-corrected QT interval (QTcF) < 450 ms for males and < 470 ms for females; (10) INR <= 1.5xULN, APTT <= 1.5x ULN. 5. Eastern Cooperative Oncology Group Behavioral Status Score (ECOG PS) of 0 or 1; 6. The investigator evaluates that the patient can comply with the protocol requirements; 7. Sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1. Patients with allergies to therapeutic drugs or hypersensitivity constitutions, and patients with autoimmune diseases; 2. There is a third space effusion (such as massive pleural effusion and ascites) that cannot be controlled by drainage or other methods; 3. Use of steroids for more than 50 days, or require long-term use of steroids; 4. Radiation therapy within 30 days prior to treatment with the first dose of study drug (within 2 weeks if palliative treatment for peripheral bone metastases and recovery from all toxicities); 5. Those with mental disorders who cannot correctly express subjective symptoms; 6. According to the judgment of the investigator, the abnormal coagulation function has clinical significance, has a bleeding tendency or is receiving thrombolytic or anticoagulation therapy; 7. Residual toxicity from previous therapy (eg, grade >= 2 hematologic, cardiovascular, or neurotoxicity). Hair loss is allowed; 8. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug taking and absorption; 9. Other malignant tumors (other than gastrointestinal tumors) occurred within 5 years before enrollment, except for cervical carcinoma in situ or skin squamous or basal cell carcinoma previously treated for the purpose of radical cure; 10. Pregnant and lactating women, those who are fertile but refuse to take contraceptive measures; 11. Those with serious heart disease or medical history, including: documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina pectoris requiring drug treatment, clinically definite heart valve disease, history of severe myocardial infarction and intractable high blood pressure; 12. Received allogeneic tissue/solid organ transplantation; 13. According to the judgment of the investigator, there are concomitant diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study; 14. The investigator determines other circumstances that are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;overall survival; | — |
Countries
China
Contacts
Public ContactLiu Xianchen
Affiliated Hospital of Nantong University
Outcome results
None listed