colorectal cancer
Conditions
Interventions
one:Fruquintinib + cardunirimab
two:Fruquintinib + PD-1/PD-L1 inhibitor
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in the study, sign the informed consent form, and have good compliance; 2. Age =18 years old; 3. Unresectable or metastatic colorectal adenocarcinoma confirmed by histology and/or cytology; 4. Previous PD-1 or (and) PD-L1 monoclonal antibody ± chemotherapy treatment progress, regardless of the number of lines; 5. The genetic test result of tumor tissue before initial treatment is: MSI-H/dMMR 6. Patients must have at least one measurable lesion (iRECIST); 7. ECOG physical status 0-1 points; 8. Expected survival =12 weeks; 9. Blood test (if there has been no blood transfusion within 14 days, and no granulocyte colony-stimulating factor or other hematopoietic stimulating factors have been used for correction within 7 days before the laboratory test) 1) Absolute value of neutrophils =1.5×109/L, platelets =100×109/L, hemoglobin concentration =9g/dL); 2) Liver function test (bilirubin = 1.5 × ULN; aspartate aminotransferase and glutamate aminotransferase = 2.5 × ULN, if there is liver metastasis, AST and ALT = 5 × ULN); 3) Renal function (serum creatinine =1.5×ULN, or creatinine clearance (CCr) =60ml/min); 4) Coagulation, international normalized ratio (INR) =1.5×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) =1.5×ULN; 5) Thyroid function, thyroid stimulating hormone (TSH) = upper limit of normal (ULN); if abnormal, FT3 and FT4 levels should be examined. If FT3 and FT4 levels are normal, you can be selected; 10. Women of childbearing potential must have a serum pregnancy test with a negative result within 14 days before treatment, and be willing to use medically recognized effective contraceptive measures (e.g., intrauterine device) during the study and within 3 months after the last dose of the study drug. , contraceptives or condoms; for male subjects whose partners are women of childbearing potential, surgical sterilization is required, or effective contraceptive methods are recommended during the study and for 3 months after the last study dose.
Exclusion criteria
Exclusion criteria: If any of the following criteria are met, this research plan must be excluded: 1. Have received anti-vascular small molecule targeted drug treatment in the past, such as fruquintinib, regorafenib, etc.; 2. Symptomatic brain or meningeal metastases (except those who have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable for brain metastases); 3. Those who have serious infections (such as intravenous infusion of antibiotics, antifungals or antiviral drugs) within 4 weeks before treatment, or have unexplained fever > 38.5 ? during screening/first administration that cannot be relieved. ; 4. Suffering from high blood pressure that cannot be well controlled by antihypertensive medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 5. Have obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (> 5 mL fresh blood within 4 weeks) wait. or treatment for a venous/venous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; or requiring the use of warfarin or Long-term anticoagulation therapy with heparin, or long-term antiplatelet therapy (aspirin =300 mg/day or clopidogrel =75 mg/day) is required; 6. During screening, it is found that the tumor invades large blood vessel structures, such as the pulmonary artery, superior vena cava, or inferior vena cava, and the researcher determines that there is a greater risk of bleeding; 7. Active heart disease, including myocardial infarction, severe/unstable angina, occurs 6 months before treatment. Echocardiography showed left ventricular ejection fraction 1×104 copies/mL or >2000 IU/ml); 3) Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies/mL), or other hepatitis or cirrhosis]; 11. Any other disease, clinically significant metabolic abnormality, physical examination abnormality or laboratory test abnormality. According to the researcher's judgment, there is reason to suspect that the patient has a certain disease or state that is not suitable for the use of study drugs (such as epileptic seizures and require treatment), or would affect the interpretation of study results, or place patients at high risk; 12. Those whose urine routine shows urine protein =2+ and 24-hour urine protein quantification >1.0g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;6-month progression-free survival rate;12-month progression-free survival rate;Disease control rate;Duration of remission;Overall survival; | — |
Countries
China
Contacts
Public ContactZhiyu Chen
Fudan University Shanghai Cancer Center
Outcome results
None listed