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Table 2 Exclusion criteria for PTPRZ1-MET fusion gene trial

From: PTPRZ1-METFUsion GENe (ZM-FUGEN) trial: study protocol for a multicentric, randomized, open-label phase II/III trial

1. Previously received c-met inhibitors or HGF-targeted drugs;

2. Antibody oncology drugs received within 30 days prior to study enrollment;

3. Previously received carmustine extended-release implants or intralesional radiotherapy;

4. Patients who could not have brain MRI;

5. Active bleeding detected by transcranial CT or MRI scan before enrollment;

6. Uncompensated hypertension with systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg after treatment with anti-hypertension drugs;

7. Negligent decompensated heart failure (NYHA graded III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmias within 3 months prior to enrollment;

8. Severe trauma or infection affecting current antitumor therapy within 4 weeks prior to enrollment;

9. ≥ Grade 3 chronic toxic reactions (excluding hair loss) according to the National Cancer Institute Common Adverse Event Evaluation Criteria (NCI-CTCAE 5.0);

10. Major surgery (excluding glioma surgery) performed within 4 weeks prior to enrollment; individuals who have undergone bone marrow biopsy, open biopsy, or intracranial biopsy within 7 days prior to screening;

11. Anti HIV ( +), or both anti HCV and HCV-RNA ( +), or HBsAg ( +) and HBV DNA > 1000 IU/ml. If HBsAg ( +) but HBV-DNA level between 1000 ~ 10,000 IU/ml, patients who were willing to use anti-viral therapy during the study period have been enrolled;

12. Other malignancies within the past 5 years that have not been effectively controlled, except for carcinoma in situ of the cervix, squamous cell carcinoma of the skin, or localized basal cell skin cancer;

13. Long-term continuous use of hematopoietic growth factor (including granulocyte colony-stimulating factor, macrophage knockdown-stimulating factor, or interleukin-11) or platelet transfusion is required to maintain platelet count ≥ 75 × 109/L and absolute neutrophil count ≥ 1.5 × 109/L;

14. Pregnancy or breastfeeding, or plan to be pregnant during the study period;

15. Other study drugs used within 30 days prior to the first administration of the investigational drug; and

16. Unsuitable to participate in this clinical trial judged by investigators