Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer

Launched by THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY · May 3, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with advanced colorectal cancer, specifically those whose cancer cannot be surgically removed. The study will look at the effectiveness and safety of a combination of three medications: Bevacizumab, Oxaliplatin, and TAS-102. It is designed for patients aged between 18 and 75 who have at least one measurable tumor and are in relatively good health. Participants need to have a life expectancy of at least 12 weeks and normal functioning of major organs.

If you or a loved one are considering joining this trial, you'll be part of an observational study, meaning that your health will be monitored closely, but you won't be receiving a placebo or alternative treatments. You will need to meet specific health requirements, such as having a good performance status (which measures how well you can carry out daily activities) and no serious heart conditions. This trial is currently not recruiting participants yet, but it aims to provide valuable information about how well this combination therapy works for people with advanced colorectal cancer.

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Eligibility criteria

• Inclusion Criteria:
• • 1. age: ≥18 years and ≤75 years;
• • 2. ECOG score 0\~1 points;
• • 3. advanced colorectal cancer patients
• • 4. According to RECIST1.1 criteria, there is at least one measurable target lesion, and tumor imaging evaluation is performed within 28 days before the first dose;
• • 5. Expected survival time ≥ 12 weeks;
• 6. Major organ function is normal, that is, the following criteria are met:
• • （1）Routine blood examination standards must meet: ANC ≥1.5×109/L; PLT≥90×109/L; Hb ≥90g/L (no blood transfusion within 14 days); (2) Biochemical tests should meet the following criteria: ALB≥30g/L; (no ALB transfusion within 14 days); TBIL≤Upper limit of normal (ULN); ALT and AST≤2.5 times upper limit of normal (ULN), if liver metastasis , then ALT and AST≤5ULN; alkaline phosphatase≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance rate≥50mL/min (CockcroftGault formula); (3) Cardiac ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) QT interval (QTcF) corrected by Fridericia method of 18-lead ECG in females \<470 ms; 7. For premenopausal or surgically sterilized female patients: Consent to abstinence or use of effective contraception during treatment and for at least 7 months after the last dose of study treatment; 8. Voluntarily joined the study and signed the informed consent.
• Exclusion Criteria:
• • 1. Patients who have received first-line standard therapy;
• • 2. Previous antitumor therapy or radiation therapy for any malignant tumor;
• • 3. concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
• • 4. Has undergone major surgical procedures not related to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
• 5. Serious heart disease or discomfort, including but not limited to the following:
• • Diagnosed history of heart failure or systolic dysfunction (LVEF \< 50%)
• • High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \>100 bpm, significant ventricular arrhythmia (eg, ventricular tachycardia), or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV blocklag)
• • Angina pectoris requiring antianginal drug treatment
• • Clinically significant heart valve disease
• • ECG showing transmural myocardial infarction
• • Poorly controlled hypertension (systolic \> 180 mmHg and/or diastolic \> 100 mmHg)
• • 6. Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;
• • 7. Known history of allergies to the drug components of this regimen; history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• • 8. Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study drug;
• • 9. Serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition in which the patient is considered unsuitable for participation in this study by the investigator.
• Dropout/Rejection Criteria:
• • 1. The efficacy and/or safety evaluation cannot be performed due to the medication not prescribed in this protocol;
• • 2. Participating in other anti-tumor treatments while participating in this study will be assessed by the investigator as affecting the efficacy evaluation.
• Termination criteria:
• • 1. The subject withdraws informed consent and requests to withdraw;
• • 2. During the course of the study, the subject has a pregnancy event;
• • 3. Subjects who cannot tolerate toxicity;
• • 4. Disease progression;
• • 5. Other circumstances in which the investigator considers it necessary to withdraw from the study.