Rosuvastatin combined with FOLFIRI chemotherapy regimen to improve the efficacy of advanced colorectal cancer

Phase 1

• Conditions: colorectal cancer

• Registration Number: ChiCTR2400088782
• Lead Sponsor: South China Hospital of Shenzhen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All enrolled subjects must meet all the following criteria:<br>1) Diagnosed unresectable advanced colorectal cancer;<br>2) Presence of at least one measurable metastatic lesion;<br>3) Patients who was evaluated as SD after treatment with the FOLFIRI regimen;<br>4) ECOG score is 0-1;<br>5) Age not exceeding 75 years old;<br>6) Patients with dyslipidemia or atherosclerosis;<br>7) After communication, subjects willing to participate in this study, promise to take the medication according to the doctor's advice, and can follow up and communicate on time.

Exclusion Criteria

Any candidate subject who meets any of the following criteria will be excluded from this study:<br>1) Any of the following conditions: People with immune deficiency or impairment (such as AIDS patients); People who are using immunosuppressive drugs or undergoing radiotherapy; People who are suffering from fever and acute infectious diseases, including active tuberculosis, or are currently receiving anti-tuberculosis treatment; People who severe chronic cardiovascular or cerebrovascular disease or chronic kidney disease;<br>2) Merge with other tumors;<br>3) Known immunodeficiency, acquired or congenital immunodeficiency diseases, or history of organ transplantation;<br>4) People with severe cardiovascular or cerebrovascular diseases, such as myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism, etc.;<br>5) Significant dysfunction of major visceral organs, such as creatinine >1.5 times the upper limit of normal, aspartate aminotransferase, alanine aminotransferase, total bilirubin >1.5 times the upper limit of normal, etc.;<br>6) People who suffer from fever and body temperature exceeding 38°C, or significant active infections that could affect the clinical trial, such as acute pneumonia, active tuberculosis, severe urinary tract infection, etc.;<br>7) People who are allergic to the drug or its ingredients;<br>8) Any condition that the investigator believes may increase the risk of subjects or interfere with the conduct of the clinical trial.<br>

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate;

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival;