Advanced solid tumors
Conditions
Interventions
experimental group:Docetaxel albumin injection (albumin-binding type)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 (inclusive) years, regardless of gender. 2. The first stage: the enrolled subjects must have advanced, recurrent or metastatic solid tumors confirmed by histology or cytology, and have no standard treatment plan, or have no effect or tolerance to the standard treatment plan, or have no conditions to accept the standard treatment. Stage 2: Patients with advanced gastric cancer confirmed by histology or cytology. 3. Patients with at least one measurable focus, the definition of measurable focus comes from the RECIST version 1.1 standard. 4. ECoG physical fitness score: 0-1. 5. Patients expected to survive for more than 3 months. 6. Patients whose main organ functions meet the following standards within 7 days before the treatment (no blood transfusion, EPO, G-CSF or other medical support treatment within 14 days before the administration of the study drug): blood routine: neutrophil absolute count >= 1.5 * 10^9 / L, platelet >= 100 * 10^9 / L, hemoglobin (HB) >= 90g / L or >= 5.6 Mmol / L; renal function: = 50ml / min; liver function: total bilirubin <= 1.5 * ULN, ALT and AST <= 2.5 * ULN. 7. Women should agree to use contraceptive measures (such as IUD, contraceptive or condom) during the study period and within 6 months after the end of the study; serum pregnancy test is negative within 7 days before the study is to be included in the group, and must be non lactating subjects; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period. 8. The subjects should have informed consent to the study before the trial, and sign the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients who have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first use of the study drug, except the following: Nitrosourea (such as carmustine, lomustine, etc.) or mitomycin C are within 6 weeks before the first use of the study drug; oral fluorouracil and small molecule targeted drugs are within 2 weeks before the first use of the study drug or 5 half lives of the known drugs (whichever is longer); Chinese medicine with anti-tumor indications is within 2 weeks before the first use of the study drug; 2. Patients who have received other unlisted clinical study drugs within 4 weeks before the first use of study drugs; 3. Patients who have undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first use of the study drug; 4. Patients who received systemic glucocorticoids (prednisone > 10mg / day or equivalent) or other immunosuppressive drugs within 14 days before the first use of the study drug, except for the following: local, eye, intra-articular, intranasal and inhaled glucocorticoids; short-term use of glucocorticoids for preventive treatment (such as prevention of contrast agents Allergy); 5. Patients who had used CYP3A4 strong inhibitor or strong inducer within 14 days before the first use of the study drug; 6. Patients who are allergic to any excipients or taxanes of the study drug; 7. The adverse reactions of the previous anti-tumor treatment have not been restored to CTCAE 5.0 grade evaluation 1000 copies / ml or 200iu / ml), preventive antiviral therapy other than interferon is allowed; hepatitis C virus infection; 12. Patients with a history of serious cardiovascular disease, including but not limited to: (1) There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II- III degree atrioventricular block, etc; (2) He had a history of myocardial infarction, angina pectoris, angioplasty and coronary artery bridging surgery; (3) The QT / QTc interval of baseline ECG was prolonged (QTCF > 480ms); (4) Serious arrhythmia, or need to take antiarrhythmic drugs (excluding anticoagulants, anticoagulant related coagulation function must meet the inclusion criteria); (5) Baseline echocardiography (echo) or multi gated acquisition (MUGA) or left ventricular ejection fraction (LVEF) = 150 mmHg and / or diastolic blood pressure >= 95 mmHg, despite optimal treatment); (8) Previous or current cardiomyopathy. 13. Patients with other serious systemic diseases are not suitable for clinical trials according to the judgment of researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence and frequency of AE, SAE and DLT;MTD (if any), clinical recommended dosage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indicators: including but not limited to AUC0-last, AUC0-8, Cmax, Tmax, t?and CL/F.; Effectiveness indicators: overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), and duration of response (DOR); | — |
Countries
China
Contacts
Public ContactBi Feng
West China Hospital of Sichuan University
Outcome results
None listed