Solitary Fibrous Tumors of the Central Nervous System
Conditions
Interventions
Experimental group:Combination therapy with pyrotinib and ceritinib.
Sponsors
Sanbo brain hospital capital medical university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide informed consent prior to undertaking any study protocol-related procedures; 2. Age 18-75 years old; Male and female; 3. Patients diagnosed with central nervous system SFT by pathology and confirmed tumor recurrence by imaging; 4. Have not received targeted therapy for HER2 or ALK in the past; 5. Asymptomatic or treatment-experienced patients with relapsed CNS SFT who do not require urgent neurosurgical intervention or dehydration therapy and glucocorticoid therapy are allowed to enroll, including: a. Untreated relapsed CNS SFT found at cranial MRI/CT comparative screening; b. Relapsed CNS SFT that has stabilized or progressed after prior local therapy; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0~1; 7. Have at least one measurable lesion according to RECIST 1.1; 8. LVEF within 28 days at screening>=50%; 9. Expected survival time at screening>=12 weeks; 10. Good organ and bone marrow function within 28 days prior to enrollment, defined as follows. This criterion must also be met when the laboratory tests are repeated within 3 days before the first day of cycle 1. Note: Blood transfusions (red blood cells or platelets) or administration of G-CSF are not allowed within 2 weeks prior to the day of assessment of bone marrow function: - Absolute neutrophil count (ANC) >=1.5×10^9/L (banded neutrophils and lobulated nuclear neutrophils), platelets >=100×10^9/L and Hb >= 90 g/L [no blood transfusion or no erythropoietin (EPO) therapy within 7 days prior to enrollment]. - Liver: total bilirubin = 2.5 g/dL. - Kidney: creatinine clearance (CCr) measured by Cockcroft-Gault method > = 30 mL/min (using actual body weight); - International normalized ratio (INR) and prothrombin time (PT) =4 weeks; Radiation therapy, including palliative stereotactic radiotherapy to the head > = 4 weeks; Whole brain radiotherapy >=2 weeks; 12. The contraceptive measures used by male or female subjects should comply with the contraceptive method requirements of local regulations for clinical research subjects; 13. Females of childbearing potential who are sexually active with a non-sterilized male partner with a negative pregnancy test (urine or serum); 14. Female subjects must be postmenopausal for 1 year, surgically sterile, or use highly effective contraception (highly effective contraception is defined as a contraceptive method with an annual failure rate of less than 1% when adhered to and used correctly). Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective contraceptive method starting at screening and must agree to continue using such contraception for 7 months after the last dose of study treatment. Female patients are not allowed to donate eggs and breastfeed during the study and for 7 months after the last dose of study treatment. Non-sterilized male partners of women of childbearing potential must use a male condom containing spermicide during this period (only condoms in countries where spermicide has not been approved). This is acceptable if the subject's preferred daily lifestyle is not to engage in heterosexual sex (abstinence)
Exclusion criteria
Exclusion criteria: 1. Not suitable for use with any drug in the study. According to the local prescription information, subjects with pyrotinib and ceritinib are not allowed to be enrolled in this study; 2. Have previously received the investigational drug (pyrotinib or ceritinib) in this study, or have received any other TKI or ADC drug treatment for ERBB2 and ALK in the past; 3. Receiving any concomitant anti-tumor therapy; 4. Concurrent enrollment in another clinical study, unless the study is an observational (non-interventional) clinical study or during the follow-up period of the interventional study; 5. Refractory nausea, vomiting and diarrhea, chronic gastrointestinal diseases or previous major bowel resection; 6. Presence of substance abuse or any other medical condition that, in the opinion of the investigator, may interfere with the subject's participation in the clinical study or the evaluation of the results of the clinical study, such as clinically significant cardiac or psychological illness; 7. Has a history of another primary malignancy, with the following exceptions: cured malignancy with no known active disease and low potential risk of recurrence within 5 years prior to the first dose of study treatment. Exceptions include having received a potentially curative cure Treated basal cell carcinoma of the skin and squamous cell carcinoma of the skin, adequately resected non-melanoma skin cancer, cured in situ disease, other cured solid tumors; 8. Toxicity from prior anticancer therapy that has not resolved, defined as toxicity that has not resolved to Grade =1 or baseline level (except alopecia). Note: Subjects may be enrolled with chronic, stable Grade 2 toxicity (defined as not progressing to Grade >2 within at least 3 months prior to first exposure to study intervention and managed by standard therapy) that is considered by the investigator to be related to prior anticancer therapy, including: Chemotherapy-induced neuropathy fatigue Residual toxicity from prior immuno-oncology therapy: Grade 1 or Grade 2 endocrine disease, These may include: a) Hypothyroidism/Hyperthyroidism b) Type 1 diabetes c) Hyperglycemia d) Adrenal insufficiency e) Adrenitis f) skin hypopigmentation (vitiligo); 9. There must be at least a 2-week interval between the end of whole brain radiotherapy or stereotactic radiotherapy and enrollment. 10. Subjects with active primary immunodeficiency, known HIV infection, or active hepatitis B or hepatitis C infection, such as subjects with serological evidence of viral infection within 28 days prior to Day 1 of Cycle 1. Subjects with positive HCV antibodies can only be enrolled in this study if the polymerase chain reaction shows that HCV RNA is negative. If required by local regulations or IRB/EC, subjects should be tested for HIV prior to enrollment. Subjects with prior or remission hepatitis B virus (HBV) infection may be enrolled only if they meet all of the following criteria: HBsAg(-) (discontinuation of antiviral therapy > 6 months), anti-HBC( ( IgG or total Ig), undetectable HBV DNA, no cirrhosis or liver fibrosis on previous imaging or biopsy, no history of HCV co-infection or HCV co-infection. Consult with a local hepatitis B specialist during and after the study. 11. Uncontrolled infections requiring intravenous antibiotics, antivirals, or antifungals; 12. Subjects with a history of myocardial infarction (MI), symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels highe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended Phase 2 Dose, RP2D;Median progression-free survival, mPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE incidence;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactFuxiao Jun
Sanbo brain hospital capital medical university
Outcome results
None listed