Colorectal cancer
Conditions
Interventions
Observation group:None
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years, regardless of gender; 2) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2, with an expected survival of more than 3 months; 3) Advanced colorectal cancer confirmed by cytopathology or histopathology; 4) Laboratory test results within 7 days prior to screening (including 7 days): Neutrophil count >= 1.5×10^9/L, platelet count >= 75×10^9/L, hemoglobin >= 90g/L, serum total bilirubin = 30g/L; serum creatinine = 60ml/min. 5) At least one measurable lesion (RECIST 1.1 criteria); 6) Patients with newly diagnosed advanced disease who have not received any prior treatment, or who have failed first-line chemotherapy and are planning to undergo second-line chemotherapy; or who have failed both first-line and second-line chemotherapy and are planning to undergo subsequent-line chemotherapy; 7) Subjects (or their legal representatives/guardians) must sign an informed consent form, indicating that they understand the objectives of the study, are familiar with the necessary study procedures, and are willing to participate.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women of childbearing potential who are not taking adequate contraceptive measures; 2) History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ or non-melanoma skin cancer; 3) Patients with uncontrolled brain metastases or central nervous system metastases, significant intracranial hypertension, or neuropsychiatric symptoms; 4) Patients with the following serious or uncontrolled illnesses: severe heart disease that remains unstable despite treatment; myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment; established neurological or psychiatric disease, including dementia or epileptic seizures; severe or uncontrolled infection; active disseminated intravascular coagulation or patients with a significant bleeding tendency; 5) Significant impairment of vital organ function; 6) Patients with pleural effusion or ascites, resulting in respiratory syndrome (>= CTCAE grade 2 dyspnea), requiring local treatment; 7) Other conditions in which the investigator deems the patient unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhiyu Chen
Fudan University Shanghai Cancer Center
Outcome results
None listed