XELOX+Bevacizumab and XELIRI + Bevacizumab Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer

Last updated: April 29, 2018
Sponsor: Harbin Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Chemotherapy

Treatment

N/A

Clinical Study ID

NCT03511183
2018-51-IIT
  • Ages 18-75
  • All Genders

Study Summary

Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time .In the past, the classical treatment regiment was to change other drug after tumor progressed. In theory, the continuous use of such a drug could shortening the patient's drug resistance time. It has been shown that the alternate use of the two drug combinations is reasonable in clinical. This application can not only further improve the curative effect but also significantly reduce the side effects. So the investigators are going to carry out a prospective phase II clinical study. The control group change to second-line treatment after progression of first-line drugs. The experimental group use the first line and the second line,alternately, for every two cycles. The combination of bevacizumab is a first line development, and the second line can still be used . Objective to compare the clinical value of XELOX + bevacizumab and XELIRI + bevacizumab alternation regimen in the first-line treatment of advanced colorectal cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed as colorectal adenocarcinoma by histopathology and/or cytology.

  2. Patients could not receive surgical resection.

  3. Never received chemotherapy or radiotherapy.

  4. 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.

  5. Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score

  6. The main organs function is normal, which meets the following requirements. (1) Bloodroutine examination,(no blood transfusion within 14 days).

  7. Hemoglobin(HB)≥90g/L;

  8. Absolute neutrophil count (ANC) ≥1.5×10^9/L;

  9. Blood platelet (PLT)≥80×10^9/L; (2) Biochemical examination should comply withthe following criteria:

  10. Bilirubin(BIL) <1.5 times of the upper limit of normal value (ULN)

  11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5ULN (liver metastasis ALT and AST<5ULN).

  12. Serum Cr≤1*ULN, creatinine clearance rate≥50ml/min (Cockcroft-Gault formula)

  13. The expected survival time more than 3 months;

  14. The physicians plan to use XELOX + bevacizumab chemotherapy or XELIRI+bevacizumabchemotherapy.

  15. Patients voluntarily joined the study and signed informed consent form (ICF).

  16. 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:

  1. There is a case of heart disease in any of the following situations. (1)Recentpublications have the following heart disease (within 6 months)

  2. Acute coronary artery syndrome

  3. Acute heart failure (grade III or IV of NYHA classification)

  4. 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.

  1. There are many factors that affect the absorption of oral drugs (such as unable toswallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).

  2. ECOG score≥2

  3. Abnormal coagulation function (INR>1.5ULN, Activated partial thromboplastintime(APTT)>1.5ULN), with bleeding tendency.

  4. There is any history of allergy or hypersensitivity in this research's drug oradjuvant.

  5. HIV infection and/or active hepatitis B virus infection.

  6. Any condition that may damage the safety of patients or the integrity of researchdata, including serious medical risk factors, physical condition and laboratoryabnormality.

  7. 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

  8. Pregnant or lactating women;

  9. Other conditions which the doctor think not suitable for inclusion.

Study Design

Total Participants: 66
Study Start date:
March 01, 2018
Estimated Completion Date:
June 01, 2020

Connect with a study center

  • Harbin Medical University

    Harbin, Heilongjiang
    China

    Active - Recruiting

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