metastatic colorectal cancer
Conditions
Interventions
Cohort 1 (fruquintinib monotherapy
fruquintinib + chemotherapy ± immunotherapy after progressive disease):None
Cohort 2 (fruquintinib + chemotherapy/immunotherapy
fruquintinib ± chemotherapy ± immunotherapy after progressive disease (different from the former one)):None
Cohort 3A (fruquintinib + capecitabine (refer to No. 4 in inclusion criteria)):None
Cohort 3B (bevacizumab + capecitabine (refer to No. 4 in inclusion criteria)):None
Cohort 4 (fruquintinib monotherapy):None
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood this study and voluntarily signed the informed consent form; 2. The age is 18 to 75 years old (inclusive); 3. mCRC confirmed by histopathology or cytology; 4. For Queue 1 and Queue 2, the number of lines for the first treatment of furosemide shall not exceed 3; Queue 3 should have received first-line FOLFOXIRI (with or without bevacizumab/cetuximab) treatment before, and then entered the group within 6 weeks after the end of chemotherapy according to the investigator's choice, in which queue 3A received maintenance treatment with furquine combined with capecitabine, and queue 3B received maintenance treatment with bevacizumab combined with capecitabine. Queue 4 is the progression of the disease after receiving first-line FOLFOXIRI (with or without bevacizumab/cetuximab) treatment, and then receiving furosemide treatment; 5. According to the definition of RECIST1.1 version 1.1, there are measurable lesions (except for patients who were still in CR before enrollment). A lesion that has received local treatment in the past can only be regarded as a measurable lesion if it has made definite progress; 6. The expected survival period exceeds 12 weeks; 7. ECOG score 0-2; 8. Have sufficient bone marrow function, renal function and liver function; 9. Fertile women must have negative serum pregnancy test results within 7 days before taking medicine for the first time. Fertile male or female patients voluntarily use effective contraceptive methods, such as double barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. during the study period and within 90 days of the last study. All female patients will be considered as fertile, unless the female patient has gone through natural menopause, artificial menopause or sterilization (such as hysterectomy and bilateral appendectomy).
Exclusion criteria
Exclusion criteria: 1. There is central nervous system (CNS) metastasis or cancerous meningitis (meningeal metastasis); 2. The toxicity related to previous anti-tumor therapy has not recovered to = CTCAE grade 1, except alopecia and peripheral neurotoxicity = CTCAE grade 2; 3. Uncontrollable malignant pleural effusion, ascites or pericardial effusion (defined as the inability to be effectively controlled by diuretics or puncture according to the judgment of the researcher); 4. Being active or having suffered from autoimmune diseases or immunodeficiency; 5. The patient currently has digestive tract diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding from unresectable tumor, or serious gastrointestinal dysfunction (infection, obstruction, diarrhea =1, etc.), or other conditions that may cause gastrointestinal bleeding and perforation as determined by the researcher; 6. Patients with obvious evidence of bleeding tendency or medical history within 2 months before the first medication (bleeding > >30 mL within 2 months, hematemesis, black stool and bloody stool) and hemoptysis (fresh blood > >5 mL within 4 weeks); 7. During the screening, it was found that the tumor invaded large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, etc., and the researchers judged that there was a greater risk of bleeding; 8. The patient currently has hypertension that cannot be controlled by drugs, which is defined as systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 9. Arterial thrombosis or deep vein thrombosis occurred within 6 months before the first medication, or stroke and/or transient ischemic attack occurred within 12 months; 10. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before the first medication, congestive heart failure with new york Heart Association (NYHA) grade =2 and left ventricular ejection fraction (LVEF) 1×104 copies /mL or > 2000 IU/mL when hepatitis B virus surface antigen (HBsAg) and/or hepatitis B virus core antibody (HbcAb) are positive; It is known that HCV antibody is positive and HCV RNA >1×103 copies /mL], or other hepatitis and clinically significant moderate and severe cirrhosis; 14. Severe infection (defined as systemic infection requiring intravenous antibiotics) occurred within 4 weeks before the start of study treatment, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia; 15. Unable to take drugs orally, previous surgical history or serious gastrointestinal diseases, such as dysphagia and active gastric ulcer, which the researchers think may affect the absorption of research drugs; 16. Major surgery was performed within 4 weeks before the drug was given for the first time; Or researchers evaluate clinically significant unhealed wounds and fractures; Or it is expected that major surgery (except surgery for diagnosis) will be required during the study. Except those who have received tissue puncture or endoscopic biopsy wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total progression-free survival (cochort 1, 2);Progression-free survival (cochort 3, 4);Second progression-free survival (cochort 1, 2); | — |
Secondary
| Measure | Time frame |
|---|---|
| First progression-free survival (cochort 1, 2);Objective response rate;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactJian Li
Beijing Cancer Hospital
Outcome results
None listed