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

Last updated: August 27, 2021
Sponsor: Jiangsu Cancer Institute & Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT04324476
JS-GI1902
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18-75 years old;
  2. Patients with advanced colorectal adenocarcinoma diagnosed by histopathology, or withmetastasis more than 12 months after radical operation, and the metastasis could notbe removed;
  3. ECOG score ≤ 2, estimated survival time ≥ 3 months;
  4. 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 isnot higher than 2.5 times of the upper limit of normal value, serum liver enzyme inpatients with liver metastasis is not higher than 5 times of the upper limit of normalvalue, serum bilirubin level is not higher than 1.5 times of the upper limit of normalvalue, serum creatinine level is not higher than 1.5 times of the upper limit ofnormal value;
  5. At least one lesion can be measured by CT or MRI;
  6. No other history of malignant tumor;
  7. Those who are fertile but willing to take contraceptive measures;
  8. Sign the written informed consent.

Exclusion

Exclusion Criteria:

  1. Patients with allergic, hypersensitive constitution and autoimmune diseases;
  2. There are only unmeasurable lesions, such as hydrothorax and ascites, carcinomatouslymphangitis, diffuse liver invasion and bone metastasis; No measurable or nonassessable lesions;
  3. Pregnant or lactated women;
  4. Uncontrolled symptomatic brain metastasis or mental disorder can not correctlydescribe subjective symptoms;
  5. Major organ failure;
  6. Affecting drug administration, absorption, distribution, metabolism, excretion, etc.the patient has uncontrollable epileptic attack, central nervous system disorder orloss of self-knowledge due to mental disease, physiological or pathologicalmalnutrition, chronic diarrhea, and cachexia;
  7. Patients with complete or incomplete ileus;
  8. Patients with serious heart disease or history, including documented history ofcongestive heart failure, high-risk uncontrolled heart rate disorder, angina requiringdrug treatment, clinically clear history of heart valve disease, serious myocardialinfarction and stubborn hypertension;
  9. Severe uncontrollable infection;
  10. Alcohol and /or drug abuse or poor compliance of the investigator's judgment.

Study Design

Total Participants: 50
Study Start date:
September 01, 2019
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Jiangsu Cancer Institute & Hospital

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

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