Colorectal cancer
Conditions
Interventions
1:Combination targeted therapy and chemotherapy
Treatment group:Targeted therapy combined with chemotherapy plus atorvastatin calcium
Sponsors
Shanghai Geriatric Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Histopathologically confirmed colorectal cancer with liver metastasis following curative surgery; 2.Pathological type: adenocarcinoma,Molecular profile: KRAS/NRAS mutation-positive, pMMR/MSS subtype; 3.AJCC TNM Stage IV (American Joint Committee on Cancer staging); 4.At least one measurable liver lesion confirmed by CT/MRI/PET imaging per RECIST 1.1 criteria; 5.Age 18–80 years, any gender; 6.ECOG performance status: 0–1; 7.No prior intravenous or oral anticancer therapy; 8.Life expectancy >3 months; 9.Normal peripheral blood parameters, and no significant impairment of heart, liver, or kidney function; Essentially normal electrocardiogram (ECG) findings;
Exclusion criteria
Exclusion criteria: 1.Patients with psychiatric disorders, or those who are pregnant/lactating; 2.Current participation in other drug trials; 3.History of concurrent medications with drug-drug interactions with statins; 4.Known hypersensitivity to atorvastatin or structurally similar compounds; 5.Comorbidities including:Active liver cirrhosis, uncontrolled concurrent illnesses, chronic myopathy, active hepatitis and unexplained persistent elevation of serum transaminases; 6.Deemed ineligible by investigator assessment; 7.Pelvic radiotherapy or palliative bone radiotherapy within 4 weeks prior to first dose; 8.Inability to swallow oral medications or gastrointestinal disorders affecting drug absorption/metabolism (e.g., uncontrolled nausea/vomiting, obstruction, malabsorption); 9.Symptomatic/untreated CNS metastases requiring intervention (surgery/radiation/corticosteroids) or spinal cord compression; 10.History of non-colorectal malignancies (synchronous/metachronous);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of response;Overall survival;Time to progression;clinical biochemical lipid metabolism parameters;; | — |
Countries
China
Contacts
Public ContactQi Li
Shanghai Geriatric Medical Center
Outcome results
None listed