| Eligibility |
Inclusion Criteria:
1. Provide written informed consent.
2. Willing to return to enrolling institution for follow-up.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
4. Life expectancy > 3 months.
5. Patients diagnosis with metastatic pheochromocytoma or paraganglioma that is
unresectable.
6. Laboratory requirements:
1)Absolute granulocyte count (AGC) greater than 1.5 x 109/L; 2)Platelet count greater than
80 x 109/L; 3) Hemoglobin greater than 90g/L; 4) Serum bilirubin less than 1.5 x upper
limit of normal (ULN); 5)Serum aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) less than 2.5 x ULN; 6) Serum creatinine less than 1.5 x ULN or
creatinine clearance (CCr)=60ml/min; 7.Doppler ultrasound assessment: left ventricular
ejection fraction (LVEF) = lower limit of normal value (50%).
Exclusion Criteria:
1. Any of the following:Pregnant women,Nursing women,Men or women of childbearing
potential who are unwilling to employ adequate contraception.
2. Patients who have previously used other anti-vascular targeted drugs, such as
sunitinib, bevacizumab, endurance, etc.
3. Chemotherapy/systemic therapy, radiotherapy, immunotherapy or surgery within 4 weeks
prior to kinase inhibitor therapy.
4. Patients with another primary malignancy within 5 years prior to starting study drug,
with the exception of adequately treated in-situ carcinoma of the uterine cervix, or
skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or
non-melanomatous skin cancer).
5. Those who have multiple factors that affect oral medications (such as inability to
swallow, chronic diarrhea, intestinal obstruction, etc.).
6. Patients with known untreated brain metastases are excluded. Patients having a history
of brain metastasis that have been previously irradiated or resected greater than 2
months prior to enrollment and are clinically and radiographically stable will be
considered for enrollment. Patients with brain metastases with symptoms or symptom
control for less than 2 months.
7. Active or uncontrolled intercurrent illness including, but not limited to 1)Patients
with unsatisfactory blood pressure control (systolic blood pressure =150 mmHg,
diastolic blood pressure =100 mmHg); 2) Patients with uncontrolled myocardial ischemia
or myocardial infarction, arrhythmia (including QTC=480ms), and uncontrolled
congestive heart failure,grade =2(New York Heart Association ); 3) ongoing or active
infection; 4) Liver cirrhosis, decompensated liver disease, active hepatitis or
chronic hepatitis require antiviral treatment; 5) Renal failure requires hemodialysis
or peritoneal dialysis; 6) Have a history of immunodeficiency, including HIV or other
acquired or congenital immunodeficiency diseases, or a history of organ
transplantation; 7) Diabetes is poorly controlled (fasting blood glucose (FBG)>
10mmol/L); 8) Urine routines suggest that urine protein is =++, and the 24-hour urine
protein content is confirmed to be greater than 1.0 g; 9) Patients who have seizures
and need treatment;
8. Any of the following conditions =< 6 months prior to registration: Cerebrovascular
accident (CVA) or transient ischemic attack (TIA); Serious or unstable cardiac
arrhythmia; Pulmonary embolism, untreated deep venous thrombosis (DVT).
9. Received major surgical treatment, open biopsy or obvious traumatic injury within 28
days before enrollment.
10. Those who have a history of psychotropic drug abuse and cannot be quit or have mental
disorders.
11. Imaging shows that the tumor has invaded important blood vessels or the investigator
judges that the tumor is very likely to invade important blood vessels and cause fatal
bleeding during the follow-up study.
12. Regardless of the severity, patients with any signs of bleeding or medical history;
within 4 weeks before enrollment, patients with any bleeding or bleeding event = CTCAE
grade 3, unhealed wounds, ulcers or fractures.
13. Participated in other clinical trials within 4 weeks.
14. Patients are using drugs that interact with Anlotinib.
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