Eligibility |
Inclusion Criteria:
- Male or female patients aged between 18 and 85 years old.
- Patients with histologically confirmed digestive tract cancers, such as esophageal
cancer, gastric cancer, small intestinal cancer, colorectal cancer, as well as
pancreatic cancer, liver cancer, gallbladder cancer, etc.
- Patients admitted for anti-tumor-related drug treatment.
- Expected survival period of more than three months.
- ECOG PS score: < 4.
- No severe psychological disorders, physical disabilities, dementia, Alzheimer's
disease, pulmonary tuberculosis, HIV/AIDS, or other infectious diseases.
- Patients must have sufficient organ and bone marrow function, meeting the following
criteria:
1. Hematological criteria:
Hemoglobin (Hb) = 90 g/L (without blood transfusion in the past 28 days).
Absolute neutrophil count (ANC) = 1.5×109/L. Peripheral blood monocytes >
1500mm3. Platelet count (PLT) = 100×109/L.
2. Biochemical criteria:
Total bilirubin (TBIL) = 1.5 × the upper limit of normal (ULN). ALT and AST =
2.5×ULN; if there is liver metastasis, ALT and AST = 5×ULN. Creatinine (Cr) =
1.5×ULN or creatinine clearance rate (CCr) = 60 ml/min (Cockcroft-Gault formula).
3. Coagulation function is sufficient, defined as international normalized ratio
(INR) or prothrombin time (PT) = 1.5 × ULN.
- Women of childbearing potential must have a negative pregnancy test (serum or urine)
within seven days before enrollment and must voluntarily use appropriate contraception
methods during the observation period and within six months after the last dose.
- Signed informed consent.
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding.
- Patients with accompanying diseases, as judged by the investigator, pose a serious
risk to patient safety or may affect the patient's ability to complete the study.
- Patients with poor compliance who refuse to undergo body composition measurements.
- Patients who experience a severe adverse event judged by the investigator as no longer
suitable for continued participation in the study or those who become unexpectedly
pregnant.
- Patients who are unwilling to continue in the clinical trial and insist on withdrawal.
- The investigator deems it necessary to terminate the study.
- Patients who were mistakenly included but did not meet the criteria.
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