Table 1 Inclusion criteria for PTPRZ1-MET fusion gene trial
1. Male or female with 18 ≤ age ≤ 65 years; |
2. Histologically confirmed secondary glioblastoma (progression from lower-grade glioma to glioblastoma) or IDH-mutant glioblastoma (Histology and IDH test reports from other hospitals are acceptable); |
3. The latest surgical sample was confirmed to be positive for the ZM fusion gene through molecular pathological testing in the central laboratory; |
4. Those who had previously received radiotherapy (including gamma knife, cyberknife, etc.) and temozolomide treatment and had tumor recurrence, or who had received temozolomide but were not suitable for radiotherapy, or who had received radiotherapy but were intolerant to temozolomide (ANC < 0.5 × 109/L or platelet count < 10 × 109/L or grade 3–4 non-hematologic toxicity excluding hair loss, nausea, vomiting, etc.); |
5. Did not receive glucocorticoid treatment within 5 days prior to enrollment, or received stable or reduced doses of glucocorticoid treatment within 5 days prior to enrollment; |
6. Pre-enrollment laboratory test results are consistent with: (1) blood count: platelet count ≥ 75 × 109/L; absolute neutrophil count ≥ 1.5 × 109/L; hemoglobin > 90 g/L; (2) blood biochemistry: aspartate aminotransferase (AST, SGOT) ≤ 3 × ULN; alanine aminotransferase (ALT, SGPT) ≤ 3 × ULN; total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN; urea nitrogen ≤ 1.5 × ULN; serum amylase ≤ 1.5 × ULN or 1.5 × ULN < serum amylase ≤ 2 × ULN without evidence of pancreatic disease; serum lipase ≤ 1.5 × ULN or 1.5 × ULN < serum lipase ≤ 2 × ULN without evidence of pancreatic disease; fasting serum triglyceride level ≤ 2.5 × ULN; (3) coagulation function: prothrombin time international standardized ratio (INR) ≤ 2.0; |
7. Karnofsky Performance Status (KPS) ≥ 60, be able to swallow the drug and keep it orally; |
8. Life expectancy of ≥ 3 months; |
9. Female participants must have a negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to enrollment if of child-bearing potential, and are required to use adequate contraception (i.e., IUD, spermicidal barrier, condom, hormonal contraceptives, or abstinence), during their participation in the study and for 3 months following the last dose administration; and |
10. Voluntarily participate in this study and sign the informed consent form, and be able to understand and comply with the requirements of the study |