| Eligibility |
Inclusion Criteria:
1. Age =18 years old, male or female.
2. Patients were diagnosed advanced solid tumors by histology or cytology (preferably
prostate cancer, gastric cancer, non-small cell lung cancer, breast cancer, esophageal
cancer, head and neck squamous cell carcinoma, ovarian cancer, liposarcoma, etc.)
whose disease progresses after standard treatment.
3. ECOG score 0~2, expected survival time =3 months.
4. Have adequate hematology and organ function, and meet the following conditions based
on laboratory test results within 7 days before the first dose:1)For those who have
not received blood transfusions, blood products or blood cytokines such as granulocyte
colony-stimulating factor (G-CSF) within 14 days of the first dose, blood routine:
neutrophil count =2.0×109/L, platelet count =100×109 /L, white blood cell count
=4.0×109/L, hemoglobin concentration =8.0g/dL. 2)Blood biochemistry: liver function:
aspartate aminotransferase and alanine aminotransferase =1.5 times the upper limit of
normal (ULN), total bilirubin =ULN. kidney function: creatinine =1.5×ULN.
5. Baseline left ventricular ejection fraction determined by echocardiography =50%,
normal or abnormal 12-lead electrocardiogram without clinical significance, QTc
interval <450ms (men) or <470ms (women), and no symptoms or signs of heart failure.
6. The functions of major organs (heart, lung, liver, kidney, bone marrow,
gastrointestinal) are basically normal or abnormal without clinical significance, and
acute toxicity caused by previous treatment is relieved to = grade 1 (except for hair
loss).
7. If the subject has been previously treated with surgery, chemotherapy, immunotherapy,
biologic therapy, targeted therapy, anti-tumor traditional Chinese medicine, or small
molecule targeted drug, the first dose should be given at an interval of 4 weeks or
more than 5 half-lives (whichever is shorter);If the chemotherapeutic agent is
mitomycin or nitrosourea, the first dose needs to be given more than 6 weeks apart.
8. The first dose was more than 6 weeks after the last radiotherapy (except palliative
radiotherapy for local pain control), and there was no previous whole-pelvic
radiotherapy (radiotherapy =30% of the bone marrow area).
9. With the consent of the individual and an informed consent form signed by the
individual or his legal representative.
10. The subject can communicate well with the researcher and complete the research in
accordance with the research regulations.
Exclusion criteria:
1. Those who have received cabazitaxel in the past.
2. Those who are severely allergic to cabazitaxel, human albumin, or alcohol.
3. Currently receiving other anti-tumor therapys.
4. Patients receiving systemic therapy with glucocorticoids (>10 mg/d prednisone or
equivalent dose of steroids) or other immunosuppressants within 14 days before the
first dose. In the absence of active autoimmune disease, inhaled or topical
glucocorticoids can be used, and hormone replacement therapy doses =10 mg/d prednisone
equivalent are allowed.
5. Those who need to use strong inhibitors or inducers of CYP3A4 within 14 days of the
first dose and during the study.
6. Those with clinically significant mental or central nervous system diseases.
7. Those with active brain metastasis.
8. Those with two or more malignant tumors (except cured non-melanoma skin cancer,
cervical cancer, thyroid cancer and gastrointestinal intramucosal cancer)
9. Subjects who have received 2 or more prior treatments with mitomycin or nitrosoureas,
or subjects who have received prior intensive therapy with autologous stem cell
transplantation.
10. Those with serious medical diseases:1)Existence of clinically important cardiovascular
and cerebrovascular diseases, including: severe or uncontrollable heart disease that
requires treatment, congestive heart failure rated = grade 3 by the New York Heart
Association (NYHA), and unstable angina that cannot be controlled by drugs. A history
of myocardial infarction within 6 months before enrollment, and severe arrhythmia
requiring drug treatment (except for atrial fibrillation or paroxysmal
supraventricular tachycardia). 2)Those with indwelling cardiac stent within 6
months.3)Uncontrolled hypertension (systolic blood pressure =160mmHg and/or diastolic
blood pressure =100mmHg), diabetes, pleural effusion, pericardial effusion, and
ascites. 4)Uncontrolled peptic ulcer, or other uncontrolled thromboembolic event.
5)Patients with interstitial lung disease, pulmonary fibrosis, or a history of
pneumonia who require steroid treatment.
11. People who are infected with HIV, HBV [those who are positive for hepatitis B surface
antigen (HBsAg) and whose HBV-DNA is higher than 1000IU/mL], HCV ( those who are
HCV-Ab positive and whose HCVRNA detection copy number is higher than normal upper
limit)and Treponema pallidum.
12. Those with a history of drug abuse.
13. Women who are pregnant or lactating. female patients of childbearing potential who
have a positive pregnancy test within 7 days before the first dose. any male and
female patients of childbearing potential do not consent to the use of a medically
recognized effective method of contraception throughout the trial and for 3 months
after final trial drug administration.
14. Those who have participated in other drug clinical trials within 28 days before the
first dose.
15. Those who have been vaccinated within 30 days before the first dose or vaccinated
during the study period (except for inactivated vaccines).
16. Other circumstances in which the researcher deems it inappropriate to participate in
this trial.
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