Advanced colorectal cancer
Conditions
Interventions
Combination therapy group:Irinotecan Hydrochloride Liposome + Anlotinib + Enlonstobart
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18, regardless of gender; 2.ECOG 0-1 ; 3.Diagnosed with colorectal cancer through histopathology or cell pathology; 4.Previously received first-line treatment with oxaliplatin or fluorouracil; 5.>=1 measurable metastatic lesion (CT/MRI, RECIST V1.1); 6.Bone marrow function: neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count (PLT) >= 90 × 10^9/L, hemoglobin (Hb) >= 90 g/L; 7.Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 g/dL; 8.Renal function: serum creatinine (Cr) = 60 ml/min (calculated according to Cockroft Gault); 9.Expected survival time>3 months; 10.Accept the combination therapy regimen of this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who have suffered from other malignant tumors within the past 5 years (excluding in situ cancer, basal cell carcinoma of the skin, etc. that have been cured and show no signs of recurrence); 2.Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment, defined as persistent signs/symptoms associated with the infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments; 3.Known active HIV infection (i.e. HIV1/2 antibody positive); 4.Merge uncontrollable systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, and a history of severe pericardial disease and other cardiovascular diseases; Uncontrollable hypertension, or a history of critical hypertension, hypertensive encephalopathy; Uncontrollable diabetes, etc; 5.Those who are known to be allergic or intolerant to the therapeutic drugs or their excipients in this study protocol; 6.Any clinical indicators indicating contraindications to chemotherapy and target immunotherapy; 7.Those who use strong inhibitors or inducers such as CYP3A4, CYP2C8, and UGT1A1; 8.Pregnant or lactating women, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial; 9.Patients with poor cognitive abilities, unable to answer questions, fill out questionnaires, or have mental disorders; 10.The researchers believe that patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of combination therapy;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Overall survival;Duratiom of Response;Time To Failure;Quality of Life; | — |
Countries
China
Contacts
Public ContactZong Hong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed