Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Feb 15, 2023
  • participants needed
    100
  • sponsor
    Jiangsu Cancer Institute & Hospital
Updated on 5 September 2021

Summary

The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer

Details
Condition Advanced Colorectal Cancer
Treatment bevacizumab, Irinotecan, Oxaliplatin, raltitrexed
Clinical Study IdentifierNCT03126071
SponsorJiangsu Cancer Institute & Hospital
Last Modified on5 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-70 years
histological and/or cytological confirmation of ACC
disease progression while on first-line palliative fluoropyrimidine-based chemotherapy or relapse within 6 months after adjuvant chemotherapy
at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter 1cmaccording to RECIST 1.1
ECOG performance status 0-1
life expectancy of at least 3 months
satisfactory main organ functionlaboratory test must meet the following criteria: hemoglobin (HGB) 90g/L, neutrophil countANC 1.5109/L, platelet countPLT 80109/L, Serum creatinineCR1.5 upper normal limitation (UNL)total bilirubin (TBil) 1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 UNL (For patients with liver metastasis, the AST/ALT must be 5.0 UNL), Alkaline phosphataseALP3 UNL(For patients with liver metastasis, the ALP must be 5.0 UNL)
written informed consent

Exclusion Criteria

prior exposure to raltitrexed
Clinically significant cardiovascular disease, for example symptomatic coronary artery disease, myocardial infarction (<=6 months before treatment start),congestive heart failure New York Heart Association NYHA>= grade 3,stroke or transient ischemic attack
Accept kidney dialysis treatment now
chronic enteropathy on unresolved bowel obstruction
previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin
the UGT1A1 _287/7_ 6A/A gene type
pregnant or lactated women
Unsuitable for the study or other chemotherapy determined by investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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