Gastrointestinal cancer
Conditions
Interventions
experimental group:Anti-angiogenesis therapy
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who understand the steps and contents of the trial and voluntarily sign the written informed consent; 2. Patients aged 18-80 years; 3. Patients with advanced gastrointestinal cancer confirmed by pathology; 4. Anti angiogenic treatment; 5. Patients with physical condition (PS) less than or equal to 1 in the eastern Cancer Cooperative Group (ECoG) of the United States; 6. Patients who have previously used other cytotoxic drugs and anti-tumor proprietary Chinese medicine should stop using them for at least 4 weeks before entering the group; 7. Patients with left ventricular ejection fraction (LVEF) >= 50% at baseline (within 28 days before randomization); 8. Those patients who do not suffer from serious hematology, liver, kidney and other diseases except the primary disease., the requirements are: (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9 / L [when granulocyte / granulocyte-macrophage colony stimulating factor (G-CSF / GM-CSF) or other medical supportive therapies are not used] ; Platelets >= 100 x 10^9 / L; Hemoglobin >= 90 g / L (in the case of no blood transfusion within 14 days or the use of medical support therapy such as blood cell factors); (2) Serum creatinine = 50 mL / min; (3) Serum total bilirubin (STB) 1.0 ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <= 2.5 x ULN (liver metastasis can accept ALT or AST <= 5 x ULN); (4) International standardized ratio (INR) <= 1.5, and activated partial prothrombin time (aPTT) <= 1.5 x ULN (unless receiving anticoagulation at the same time).
Exclusion criteria
Exclusion criteria: 1. Patients suffering from other malignant tumors at the same time, except those that have been cured or have stable disease; 2. Patients who participated in another clinical trial within 28 days before randomization (in case of McAb trial, within 5 half-life of the drug) and received active drug treatment, or were interested in participating in another clinical trial during the whole study period; 3. Patients who had received radiotherapy in the first two weeks of randomization; 4. Patients who had major surgery or severe trauma within 28 days before randomization or who are expected to have major surgery during the trial period (defined as surgery requiring more than 3 weeks of postoperative recovery period); 5. Patients with clinically significant active infection (NCI CTCAE > grade 2) who need systemic treatment; 6. Patients with systemic severe or uncontrolled underlying diseases (including dyspnea or severe lung disease at rest, metabolic disease, abnormal wound healing, ulcer or fracture, etc.) or abnormal laboratory examination, the researchers believe that the risk of administration of the test drug will be significantly increased, or the efficacy evaluation will be affected; 7. Uncontrolled hypertension (systolic >= 140 mmHg and / or diastolic >= 90 MmHg) or pulmonary hypertension or unstable angina, meet the NYHA standard history of chronic heart failure or left ventricular hypertrophy, have clinical significance of valve disease, need to treat serious arrhythmias (except for atrial fibrillation, paroxysmal supraventricular tachycardia) or patients with clinically significant conduction abnormalities on ECG; top 6 randomized During or after the treatment with neoadjuvant or adjuvant trastuzumab, the incidence of heart failure or LVEF decreased to less than 50%; 8. Patients whose non hematologic toxicity caused by previous treatment was >= 1 grade before randomization (CTCAE 4.03, except for neurotoxicity <= 2 grade caused by alopecia and chemotherapy drugs); 9. Patients with a history of human immunodeficiency virus (HIV) infection and hepatitis C antibody (HCV AB) positive, consistent with any one of them; 10. Patients with active bleeding; 11. Patients with known history of allergic reaction to the contrast medium or any of its auxiliary ingredients, known history of allergic diseases or allergic constitution; 12. The researchers think it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized Uptake Value;total metabolic tumor volume;total lesion glyclysis; | — |
Countries
China
Contacts
Public ContactJing Liang
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed