Solid tumors
Conditions
Interventions
Albumin-bounded paclitaxel:1) Weekly therapy: every 4 weeks is a cycle, and albumin paclitaxel is about 125 mg/m2
Or 2) Three weeks of treatment, albumin paclitaxel is about 260 mg/m2, d1, q3w.
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with clinical judgment that albumin-bound paclitaxel needs to be used for treatment aged 18-70 years; They voluntarily joined the study and signed an informed consent form; 2. Patients with an ECOG score of 0-1; 3. Normal major organ function (14 days prior to enrollment), i.e., meeting relevant laboratory criteria: whole blood test (without blood transfusion, hematopoietic stimulating factor, or other medication to ajust blood cell counts within 14 days before the first dose): ANC >= 1.5 x 10^9/L; PLT >= 75 x 10^9/L; HGB>=9 g/dL; Liver and renal function: Serum creatine = 50 mL/min; TBIL <= 2 x ULN; (Patients with Gilbert's syndrome can be 3 x ULN); ALT (SGPT) and AST (SGOT) <= 2.5 x ULN(Subjects with hepatocellular carcinoma or liver metastases <= 10 x ULN); Coagulation function: APTT and INR <= 1.5 x ULN (no anticoagulants or other drugs affecting coagulation function was performed within 14 days before the first dose, except when long-term use of anticoagulants was required due to definited disease); 4. Women of childbearing age should use adequate contraception from the time they sign the informed consent until 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients who failed previous treatment with taxanes for metastatic disease or relapsed in the first year after adjuvant chemotherapy; 2. Known hypersensitivity to any paclitaxel or albumin-bounded paclitaxel component. Patients with a history of uncontrolled allergic asthma; 3. Severe cardiovascular disease,e.g., heart failure( New York City Association (NYHA) class II or above). Patients with myocardial infarction, unstable arrhythmia or angina pectoris, or severe arterial or venous thromboembolism events (e.g., pulmonary embolism, deep vein thrombolism, cerebral infarction, cerebral haemmorage, including transient cerebral ischemia) within 3 months before enrollment; 4. Planning to receive live attenuated vaccine within 28 days before the first dose or during the study; 5. Within 14 days before the first dose, the patient had received anti-tumor traditonal chinese medicine approved by NMPA(including compound cantharis capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, cinobufacin capsule, etc) ,anti-tumor purpose shouled be clearly recorded in the medical record; 6. Contradited with the following medications: CYP3A4 strong inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin or St. John's herb) of (within 2 weeks prior to first dose); CYP2C8 strong inhibitor (e.g., gemfibrozil) or inducer (e.g., rifampin) (within 2 weeks prior to first dose); Potent inhibitors or inducers of P-gp. Patients were eligible to participate if they discontinued these aboved medications >= 1 week before first dose and remained off until the end of the study treatment; A low therapeutic index was used within 24 h before study administration, such as P-gp substrates Oral drugs (e.g., digoxin, dabigatran); 7. HIV-Ab or TP-Ab positiveHBsAg and/or HBcAb positive and hepatitis B virus detection value > the upper limit of normal value of the detection unit; HCV-Ab positive and HCV RNA quantification > the upper limit of normal value of the detection unit; 8. Pregnant or lactating women; women of childbearing age with positive blood pregnancy test during screening; 9. Other ineligible for trial as judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| albumin-bound paclitaxel plasma concentration;tumor size; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, Objective Remission Rate;DCR, Disease Control Rate; Disease-Free Survival (DFS) for early cancer;Progression-Free Survival (PFS) for metastic patient;OS, Overall Survival; | — |
Countries
China
Contacts
Public ContactJunyan Wu
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed