A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Jun 7, 2023
  • participants needed
    50
  • sponsor
    Jiangsu Cancer Institute & Hospital
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Updated on 7 September 2021
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Summary

The objective is to investigate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.

Description

XELOX is a commonly used chemotherapy regimen, and XELIRI has also been widely used in the second-line treatment. XELOX and XELIRI adopt the three-week regimen, and the single dose of oxaliplatin and irinotecan is large, which has a great impact on the gastrointestinal toxicity and blood toxicity of patients. Therefore, there is no lack of a two-week improved regimen with increased frequency and reduced single dose applied in clinical, so that it has good safety, exact efficacy and increase the drug delivery density. Based on the above, we should not only consider the efficiency of the three drugs, but also control the toxic reaction. The objective is to evaluate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.

Details
Condition Advanced Colorectal Cancer
Treatment Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine
Clinical Study IdentifierNCT04324476
SponsorJiangsu Cancer Institute & Hospital
Last Modified on7 September 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

18-75 years old
Patients with advanced colorectal adenocarcinoma diagnosed by histopathology, or with metastasis more than 12 months after radical operation, and the metastasis could not be removed
ECOG score 2, estimated survival time 3 months
Leucocytes 3.5 109 / L, neutrophils 1.5 109 / L, hemoglobin 100g / L, platelets 80 109 / L, serum liver enzyme in patients without liver metastasis is not higher than 2.5 times of the upper limit of normal value, serum liver enzyme in patients with liver metastasis is not higher than 5 times of the upper limit of normal value, serum bilirubin level is not higher than 1.5 times of the upper limit of normal value, serum creatinine level is not higher than 1.5 times of the upper limit of normal value
At least one lesion can be measured by CT or MRI
No other history of malignant tumor
Those who are fertile but willing to take contraceptive measures
Sign the written informed consent

Exclusion Criteria

Patients with allergic, hypersensitive constitution and autoimmune diseases
There are only unmeasurable lesions, such as hydrothorax and ascites, carcinomatous lymphangitis, diffuse liver invasion and bone metastasis; No measurable or non assessable lesions
Pregnant or lactated women
Uncontrolled symptomatic brain metastasis or mental disorder can not correctly describe subjective symptoms
Major organ failure
Affecting drug administration, absorption, distribution, metabolism, excretion, etc. the patient has uncontrollable epileptic attack, central nervous system disorder or loss of self-knowledge due to mental disease, physiological or pathological malnutrition, chronic diarrhea, and cachexia
Patients with complete or incomplete ileus
Patients with serious heart disease or history, including documented history of congestive heart failure, high-risk uncontrolled heart rate disorder, angina requiring drug treatment, clinically clear history of heart valve disease, serious myocardial infarction and stubborn hypertension
Severe uncontrollable infection
Alcohol and /or drug abuse or poor compliance of the investigator's judgment
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