solid tumor
Conditions
Interventions
Pemigatinib treatment group:N/A
Sponsors
JiangSu province hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Before the implementation of any test-related procedures, sign a written informed consent; 2. Subjects with histologically/cytologically confirmed advanced solid tumors; 3. Advanced tumor patients with FGFR mutation confirmed by genetic testing 4. No previous use of selective FGFR inhibitors (including but not limited to Erdafitinib, infigratinib, Futibatinib, etc.) 5. Subject = 18 years old; 6. At least 1 measurable or evaluable lesion according to RECIST v1.1 (solid tumor response Evaluation Criteria 1.1); 7. Expected survival =12 weeks; 8. The physical state score (ECOG PS score) was 0-2 according to the Eastern Cancer Cooperative Group; 9. Patients who were evaluated and scheduled to receive Pemigatinib therapy
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing female subjects; 2. Participated in clinical trials of other drugs within four weeks; 3. Uncontrolled concurrent diseases, including but not limited to: 1) HIV-infected persons (HIV-antibody positive) 2) Severe infections that are active or poorly controlled clinically 3) Evidence of serious or uncontrolled systemic disease (e.g., severe mental, neurological, epilepsy or dementia, unstable or un-compensable respiratory, cardiovascular, liver or kidney disease, uncontrolled hypertension (i.e., CTCAE level 2 hypertension after medication) 4) Patients with active bleeding or new thrombotic diseases who are taking therapeutic amounts of anticoagulant drugs or are prone to bleeding have abnormal coagulation function (INR> 1.5×ULN, APTT> 1.5×ULN) 4. Other subjects deemed unsuitable for inclusion by the investigator. 5. Previous use of other selective FGFR inhibitors 6. Abnormal calcium and phosphorus metabolism 7. Corneal or retinal diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objectie response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;duration of response;disease control rate;Overall survival;Adverse events (AES) and serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactChen Xiaofeng
JiangSu province hospital
Outcome results
None listed