upper gastrointestinal tumor
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The patient has good compliance, can understand the research process of this study, and sign a written informed consent; (2) Aged >= 18 years; (3) Gastric cancer/esophageal cancer patients diagnosed by histopathology or cytopathology; (4) The nutritional status is rated as B or C (using the PG-SGA Nutrition Evaluation Scale); (5) The expected survival period must be greater than 12 weeks; (6) According to the RECIST1.1 standard, the patient has at least one evaluable lesion; (7) KPS score >= 50 points or ECOG score = 70g/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet (PLT) >= 100 x 10^9/L; (9) Liver function standard: ALT, AST <= 2.5 x upper limit of normal (ULN), if there is liver metastasis, ALT, AST <= 5 x ULN; serum total bilirubin < 1.5 x ULN; (10) Renal function standard: serum creatinine <= 1.5 times the upper limit of normal; (11) Check that HCV-RNA was below the lower limit of detection within 2 months before enrollment, and HBV-DNA was less than 1 x 10^3; (12) Women who are not pregnant or breastfeeding; during the study period and within 6 months after the study treatment, women/men of childbearing age should take effective contraceptive measures;
Exclusion criteria
Exclusion criteria: 1. Paclitaxel for injection (albumin-bound type) is contraindicated, such as allergy to paclitaxel or albumin components contained; 2. There are serious concomitant diseases: such as those with diabetes who cannot be well controlled by hypoglycemic drugs, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, acute digestive tract Moderate and heavy bleeding, uncontrolled brain metastases, etc. For severe heart disease, it is necessary to evaluate the classification of heart function and exclude it from the group according to the specific circumstances, including but not limited to (1) Heart failure above NYHA II; (2) Myocardial infarction or unstable angina pectoris occurred within 6 months; (3) No efficacy after clinical intervention Good supraventricular or ventricular arrhythmia. 3. Peripheral neuropathy >= Grade II at present or in the past; 4. The cumulative use of yew-type drugs in the past has reached 10 cycles; 5. Participated in other clinical studies within 4 weeks before enrollment; 6. Patients considered by the investigator to be unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Nutritional status assessment PG-SGA score;AE; | — |
Countries
China
Contacts
The First Affiliated Hospital of USTC (West District)