Gastrointestinal cancer
Conditions
Interventions
Intervention group:oral nutritional support
Control group:Nil
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 40-75 years; 2. Patients with PS score of 0-2; 3. Patients with locally advanced or metastatic digestive tract tumors (including esophagus, stomach, colorectal, small intestine, pancreas, biliary tract and ampulla) confirmed by pathology; 4. Patients who have not received pre treatment with acupuncture (such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 5. Patients with good main organ function and examination indexes meeting the following requirements: routine blood test: hemoglobin >= 90 g / L (no blood transfusion within 14 days); neutrophil count >= 1.5 x 10^9 / L; platelet count >= 80 x 10^9 / L; biochemical examination: total bilirubin = 50 ml / min (Cockcroft Gault formula); 6. Patients who sign informed consent form; 7. For patients with good compliance, their families agreed to accept survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors at the same time, except those with cured or stable disease; 2. Pregnant or lactating women; 3. Patients who have participated in clinical trials of other drugs within three months; 4. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, ulcerative colitis, intestinal obstruction, etc.); 5. Patients with bleeding events with severe grade 3 or above in ctcae4.0 occurred within 4 weeks before screening; 6. Patients with known CNS metastasis or history of CNS metastasis before screening; 7. Patients with hypertension who cannot be well controlled by single antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 MmHg); patients with unstable angina pectoris history; patients with newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events occurred within 6 months before screening; arrhythmias (including QTCF) require long-term use of antiarrhythmic drugs and NYHA grade >= II cardiac insufficiency; 8. Patients with long-term unhealed wounds or nonunion fractures; 9. Patients with previous organ transplantation history; 10. Imaging findings showed that the tumor had invaded important blood vessels, or the patients were highly likely to invade important blood vessels and cause fatal hemorrhage according to the researchers' judgment; 11. Patients with abnormal coagulation function (PT > 16S, APTT > 43S, TT > 21s, FBG < 2G / L), bleeding tendency (14 days before randomization: INR within normal range without anticoagulant); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients with prothrombin time international normalized ratio (INR) <= 1.5, low-dose warfarin (1 Mg orally, once a day) or low-dose aspirin (not more than 100 mg daily); 12. To screen the patients who have had arteriovenous thrombosis events in the previous year, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except those who have been cured according to the researcher's judgment due to venous catheterization due to early chemotherapy) and pulmonary embolism; 13. Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; 14. Patients with a history of immunodeficiency, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 15. According to the judgment of the researchers, there are accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactJing Liang
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed