Solid tumors
Conditions
Interventions
Dose 1 group:Paclitaxel Medium and Long Chain Fat Emulsion Injection(Cholesterol Bound) 80mg/m^2
Dose 2 group:Paclitaxel Medium and Long Chain Fat Emulsion Injection(Cholesterol Bound) 175mg/m^2
Dose 3 group:Paclitaxel Medium and Long Chain Fat Emulsion Injection(Cholesterol Bound) 230mg/m^2
Dose 4 group:Paclitaxel Medium and Long Chain Fat Emulsion Injection(Cholesterol Bound) 260mg/m^2
Dose 5 group:Paclitaxel Medium and Long Chain Fat Emulsion Injection(Cholesterol Bound) 300mg/m^2
Dose 6 group:Paclitaxel Medium and Long Chain Fat Emulsion Injection(Cholesterol Bound) 345mg/m^2
Sponsors
Affiliated Hospital Of Hebei Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be eligible for this study, patients must meet all of the following criteria: (1) Age range of 18–75 years, and there is no gender limit; (2) Patients with unresectable advanced/metastatic solid tumor confirmed by histopathology and/or cytology (breast cancer and gastric cancer are preferred), who have no standard effective treatment methods, or who are ineffective in the standard treatment methods, or who do not tolerate the standard treatment methods, are suitable for paclitaxel monotherapy; (3) According to the RECIST 1.1 criteria, there should be at least one measurable target lesion during the screening period; (4) ECOG score =1; Expected survival =12 weeks (5) The main organ functions are basically normal: · Hematology: absolute neutrophil count >1.5×10^9/L; Platelet >75×109/L; Hemoglobin >90g/L or >5.6mmol/L, requiring no transfusions of concentrated red blood cells (pRBC) in the past 1 week, may allow stable doses of erythropoietin (=3 months) therapy. · Kidney: serum creatinine <1.5×ULN or glomerular filtration rate (eGFR)(MDRD formula)=30mL/min. · Liver: total bilirubin (serum)<1.5×ULN unless Gilbert syndrome or =1.5×ULN is known, but Child-Pugh score =7 (only for patients with liver tumors); AST and ALT<2.5×ULN or =5×ULN(for patients with liver tumors). ·Coagulation: International Normalized ratio (INR) or prothrombin time (PT)<1.5×ULN, unless subject is receiving anticoagulation therapy. (6) Previous treatment related toxicity must be CTCAE (version 5.0) = Level 2 upon enrollment, except for alopecia, pigmentation, and long-term toxicity caused by radiotherapy (which cannot be recovered according to the researchers); (7) For patients with Fertility: patients should agree to have effective contraception during the treatment period and at least 90 days after the last administration of the study treatment, and accept double barrier contraception, condoms, use or injection of contraceptives, Intrauterine device and other contraceptive methods. Male patients should agree to avoid sperm donation. (8) Voluntary signing of informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this study: (1) Spinal cord compression or brain and meningeal metastasis; (2) Drugs that may affect the metabolism of this product, such as CYP2C8, CYP3A4 strong inducer or suppressor, should be used in combination within 2 weeks before enrollment or during the study period; (3) Radiotherapy, chemotherapy, surgery (except diagnostic biopsy), immunotherapy or other anti-tumor (such as experimental drugs, biologics, etc.) treatment within 4 weeks prior to administration; (4) Other anti-tumor therapies must be used during the study, such as chemotherapy, targeted therapy, immunotherapy regimen, radiotherapy (except local symptomatic radiotherapy), etc.; (5) Patients with allergies (excluding mild and asymptomatic seasonal allergies) or known allergic history to yew drugs and their excipients; (6) The following serious cardiovascular and cerebrovascular events occurred within 6 months prior to administration, such as myocardial infarction, unstable angina pectoris, coronary artery bypass or peripheral artery bypass implantation, congestive heart failure, and serious cerebrovascular events (including transient ischemic attacks); Or accompanied by arrhythmia that requires treatment; And chronic heart dysfunction (NYHA grade ? and ?); (7) The QTc interval confirmed by review was prolonged (=470ms); (8) Patients with active infection requiring intravenous anti-infective therapy; (9) Positive anti-HIV test; Hbsag positive and HBV-DNA> the upper limit of normal; Active hepatitis C virus (HCV) infection; (10) Women of childbearing age who are pregnant, breastfeeding, have an intention to become pregnant or have a positive pregnancy test (urine HCG or blood HCG), and should not take effective contraceptive measures (effective contraceptive measures include sterilization, Iuds, oral contraceptives or diaphragm method) during the test period; (11) Have a history of severe neurological or mental illness and other incapacitated or cognitive abilities; (12) Drug, alcohol, drug abuse history; (13) Received other clinical trial drugs within 4 weeks prior to enrollment; (14)The intestigator believes that the subjects have any conditions that are not suitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Maximal tolerated dose (MTD), recommend dose (RD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Serious adverse events;Abnormal laboratory examination;Changes in vital signs;Pharmacokinetic index;Efficacy endpoints (ORR, PFS, OS); | — |
Countries
China
Contacts
Public ContactAimin Zang
Affiliated Hospital Of HeBei University
Outcome results
None listed