Gastric Cancer
Conditions
Interventions
Experimental Group:Albumin-bound Paclitaxel+apatinib
Control Gtoup:Paclitaxel+apatinib
Sponsors
The Affiliated Tumor Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. pathologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction after first-line chemotherapy failure; 2. volunteer to participate in the study with good compliance and ability to cooperate with experimental observation. All subjects should sign the informed consent form before starting the study; 3. No Taxus drugs have been used in previous chemotherapy; 4. at least one measurable lesion , (with lesions >=20mm on conventional CT or MRI scans or >=10mm on spiral CT) 5. aged from 18 to 74, in good physical condition, with ECOG=3.0x10^9/L; Absolute neutrophil count >=1.5x10^9/L;Platelet >=100x10^9/L; HGB >=9.0g/dL; (2) liver function: in subjects without liver metastasis: aspartate transferase =3 g/dL; (3) Renal function: serum creatinine =40 mL/minute (using the Cockcroft/Gault formula);Urine protein negative; (4) coagulation function: international normalized ratio 1.5 ULN without clinical or radiological confirmation of pancreatitis, the patient can be included.Amylase 1.5 ULN without clinical or radiological confirmation of pancreatitis, the patient can be included. Alkaline phosphatase <=2.5 ULN, bone metastasis subjects, ALP<=5 ULN; 8. male subjects and women of childbearing age must use contraception within 24 weeks from the start of the first study drug to the last study drug.
Exclusion criteria
Exclusion criteria: 1. active brain metastasis or meningeal metastasis. Subjects with brain metastasis who have been treated shall meet the following conditions before being enrolled: (1) MRI demonstrated no progress after treatment >=4 weeks; (2) Treatment should be completed within 28 days before the first dose; 2. subjects with active tuberculosis (TB) or a history of active TB infection less than 48 weeks prior to screening, whether treated or not; 3. recent use of hormone therapy; 4. existing severe acute infection and not under control; Or have suppurative and chronic infection, wound delay does not heal; 5. previously serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and refractory hypertension; New York Heart Association Grade >=grade II cardiac dysfunction; 6. Patients with uncontrolled neurological, psychiatric or psychiatric disorders, poor compliance, and failure to cooperate and describe treatment responses; 7. pregnant or breast-feeding women, or female patients who are fertile but do not take contraceptive measures; 8. patients with other incurable malignant tumors.Primary brain tumor or central nerve metastatic tumor condition is not controlled, with obvious high cranial pressure or neuropsychiatric symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactTang Yong
The Affiliated Tumor Hospital of Xinjiang Medical University
Outcome results
None listed