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

• Status: Recruiting
• Trial end date: 2023-02-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Cancer Institute & Hospital
• Treatments: Bevacizumab; Camptothecin; Irinotecan; Oxaliplatin; Raltitrexed

Criteria

Inclusion Criteria:

• 18-70 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 ≥ 1cm（according to RECIST 1.1）

• ECOG performance status 0-1

• life expectancy of at least 3 months

• satisfactory main organ function，laboratory test must meet the following criteria:

hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 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 phosphatase（ALP）≤3 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 *28（7/7）*6（A/A） gene type;

• pregnant or lactated women;

• Unsuitable for the study or other chemotherapy determined by investigator.