Status:
NOT_YET_RECRUITING
Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Advanced Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is a single-arm, prospective, open-label observational clinical study to evaluate the efficacy and safety of Bevacizumab combined with Oxaliplatin and TAS-102 in patients with advanced unre...
Detailed Description
Eligible subjects received Bevacizumab in combination with Oxaliplatin and the TAS-102 investigational drug, and Bevacizumab and Oxaliplatin were administered intravenously on day 1 of each cycle. Med...
Eligibility Criteria
Inclusion
- age: ≥18 years and ≤75 years;
- ECOG score 0\~1 points;
- advanced colorectal cancer patients
- 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;
- Expected survival time ≥ 12 weeks;
- 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
- Patients who have received first-line standard therapy;
- Previous antitumor therapy or radiation therapy for any malignant tumor;
- concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
- 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;
- 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)
- Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;
- 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;
- 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;
- 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:
- The efficacy and/or safety evaluation cannot be performed due to the medication not prescribed in this protocol;
- Participating in other anti-tumor treatments while participating in this study will be assessed by the investigator as affecting the efficacy evaluation.
- Termination criteria:
- The subject withdraws informed consent and requests to withdraw;
- During the course of the study, the subject has a pregnancy event;
- Subjects who cannot tolerate toxicity;
- Disease progression;
- Other circumstances in which the investigator considers it necessary to withdraw from the study.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05364489
Start Date
June 15 2022
End Date
June 15 2027
Last Update
May 20 2022
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