Colorectal Cancer
Conditions
Interventions
Study group:Fruquintinib + XELOX
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be enrolled in the study: 1. Age 18-75 years; 2. fully understand the study, voluntarily participate, and sign the informed consent form. 3. patients with histologically confirmed initial unresectable colorectal cancer and only liver metastases; 4. no use of chemotherapy for advanced tumors; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 6. at least one evaluable lesion available for disease assessment according to RECIST Version 1.1; 7. Able to take oral drugs; 8. Adequate organ function as assessed by the following laboratory requirements: white blood cell = 3.0 × 109/L, absolute neutrophil count = 1.5 × 109/L, platelet count = 100 × 109/L, hemoglobin = 9 g/dL; serum bilirubin = 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN; serum creatinine = 1.5 × ULN. 9. Male or female patients of childbearing potential who voluntarily use an effective contraceptive method during the study and for 6 months after the end of treatment; Willingness to provide written informed consent for study procedures.
Exclusion criteria
Exclusion criteria: Any of the following criteria must be excluded from the study plan: 1. with other serious diseases that, in the opinion of the investigator, endanger the patient's safety or affect the patient's completion of the study; 2. patients who have participated in other unapproved or unmarketed drug clinical trials in China within 4 weeks before enrollment and received corresponding experimental drug treatment; 3. dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory disease; 4. international normalized ratio (INR) > 1.5 or activated partial thromboplastin time (APTT) > 1.5 × ULN; 5. clinically significant electrolyte abnormalities judged by the investigator; 6. At present, patients with hypertension that cannot be controlled by drugs, defined as: systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg; current poorly controlled diabetes (fasting blood glucose level greater than CTCAE grade 2 after regular treatment); any surgery or invasive treatment or surgery (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment According to the National Cancer Institute Common Toxicity (NCI-CTC) criteria, active or uncontrolled serious infection = grade 2; 7. other malignancies within the past 5 years, except basal cell carcinoma or squamous cell carcinoma of the skin after radical surgery. Or carcinoma in situ of the cervix; Any clinically significant concurrent cardiac disease, such as cardiovascular accident, myocardial infarction, thromboembolism, or bleeding within 6 months before enrollment, congestive heart failure = New York Heart Association (NYHA) class 2; Ventricular arrhythmia requiring medication; LVEF 1g; 11. bleeding or coagulation tendency; 12. target lesions received brachytherapy (radioactive seed implantation) within 60 days before admission; 13. Any unresolved toxicity of more than CTCAE V5.0 grade 1 caused by previous anticancer treatment, excluding alopecia, lymphopenia and neurotoxicity = grade 2 caused by oxaliplatin; 14. suffering from any disease or medical condition that may jeopardize the compliance of patients or interfere with the analysis or judgment of study results; 15. Pregnant or lactating at study entry; 16. Childbearing potential but refuse contraception; 17. Other patients who are not suitable for inclusion in the study as considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug safety;RP2D;Conversion Rate;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Tumor Regression Grade;Clinical downstaging rate; | — |
Countries
China
Contacts
Public ContactZhao Peng
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed