Phase
Condition
Chemotherapy
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed as colorectal adenocarcinoma by histopathology and/or cytology.
Patients could not receive surgical resection.
Never received chemotherapy or radiotherapy.
According to the RECIST v1.1 guide, at least 1 lesions (never receivedradiotherapy),accurately measured by computed tomography (CT) or magnetic resonanceimaging (MRI) (intravenous contrast agent as the first choice),the longest diameterwas more than 10mm (except for the lymph nodes, the short axis of the lymph nodes mustbe more than 15mm), repeated measurement.
Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score
The main organs function is normal, which meets the following requirements. (1) Bloodroutine examination,(no blood transfusion within 14 days).
Hemoglobin(HB)≥90g/L;
Absolute neutrophil count (ANC) ≥1.5×10^9/L;
Blood platelet (PLT)≥80×10^9/L; (2) Biochemical examination should comply withthe following criteria:
Bilirubin(BIL) <1.5 times of the upper limit of normal value (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5ULN (liver metastasis ALT and AST<5ULN).
Serum Cr≤1*ULN, creatinine clearance rate≥50ml/min (Cockcroft-Gault formula)
The expected survival time more than 3 months;
The physicians plan to use XELOX + bevacizumab chemotherapy or XELIRI+bevacizumabchemotherapy.
Patients voluntarily joined the study and signed informed consent form (ICF).
Child bearing age women must undergo a negative pregnancy test (serum or urine) within 7 days ,and voluntarily adopt appropriate methods for contraception from the period ofunder observation and within 8 weeks of the last time they are given the drug; As formen, it is necessary to receive surgical sterilization, or agree to adopt appropriatemethods for contraception from the period of under observation and within 8 weeks ofthe last time they are given the drug.
Exclusion
Exclusion Criteria:
There is a case of heart disease in any of the following situations. (1)Recentpublications have the following heart disease (within 6 months)
Acute coronary artery syndrome
Acute heart failure (grade III or IV of NYHA classification)
Significant ventricular arrhythmia(sustained ventricular tachycardia, ventricularfibrillation and sudden death after resuscitation).
(2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patientswith severe conduction block, and permanent pacemaker is invalid (two degree andthree degree atrioventricular block, sinus arrest) (4)Unexplained syncopeoccurred within 3 months. (5)The researchers identified as uncontrol of severehypertension, or symptomatic hypertension.
There are many factors that affect the absorption of oral drugs (such as unable toswallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
ECOG score≥2
Abnormal coagulation function (INR>1.5ULN, Activated partial thromboplastintime(APTT)>1.5ULN), with bleeding tendency.
There is any history of allergy or hypersensitivity in this research's drug oradjuvant.
HIV infection and/or active hepatitis B virus infection.
Any condition that may damage the safety of patients or the integrity of researchdata, including serious medical risk factors, physical condition and laboratoryabnormality.
The high risk population carrying UGT1A1*28 (7/7) 6 (A/A) genotype or simultaneouscarrying of the UGT1A128 (6/7) *6 (A/G) genotype (the heterozygous genotype) suggeststhe exclusion of the Irinotecan
Pregnant or lactating women;
Other conditions which the doctor think not suitable for inclusion.
Study Design
Connect with a study center
Harbin Medical University
Harbin, Heilongjiang
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.