CRC
Conditions
Interventions
Experimental group :fruquintinib combined with standard chemotherapy
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years (including 18 and 75 years); 2. Understand the research procedure and content, and voluntarily sign written informed consent; 3. Advanced or metastatic colorectal adenocarcinoma confirmed by histopathology and/or cytology; 4. There was at least one measurable lesion according to RECIST 1.1; 5. Progression after previous treatment with bevacizumab plus standard first-line chemotherapy (oxaliplatin based or irinotecan based), and the time from progression to study initiation was less than or equal to four weeks; 6. Physical condition score (ECOG PS score) : 0-1; 7. Estimated survival time =3 months; 8. Major organs function well, and relevant examination indicators meet the following requirements within 14 days before enrollment: (1) Hemoglobin =90 g/L; (2) Neutrophil count >1.5×109/L; (3) Platelet count =100×109/L; (4) Total bilirubin =1.5×ULN (upper limit of normal value); (5) Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) =2.5×ULN; If liver metastases were present, ALT or AST=5×ULN; (6) Serum creatinine (Cr) =1.5×ULN or creatinine clearance (CCr)=60ml/min; (7) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)=50%; (8) Weight of 40 kg or more (including 40 kg) or BMI > 18.5; 9. Fertile women must have had a negative urine or serum pregnancy test within 7 days before enrollment and must consent to use highly effective contraception during the study and for at least 180 days after the last dose. 10.Non-sterilized men were required to agree to use highly effective contraception during the study and for at least 180 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Previous or co-existing malignant tumors. However, early stage tumors that have been cured, including basal cell carcinoma of the skin, carcinoma in situ of the cervix, and stage I lung cancer, can be included. 2. Participated in other drug clinical trials within four weeks; 3. Multiple factors affecting oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction); 4. There was a history of bleeding and any bleeding event with a severe grade of CTCAE5.0 or higher occurred within 4 weeks before screening; 5. Patients with known CNS metastases or a history of CNS metastases before screening. For patients with clinically suspected CNS metastases, CT or MRI must be performed within 28 days before enrollment to exclude CNS metastases. 6. Patients with hypertension that cannot be well controlled by single antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90mmHg); A history of unstable angina pectoris; Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTcF: =450ms in men and =470ms in women) require long-term use of antiarrhythmic drugs and New York Heart Association grade =II cardiac insufficiency; 7. Long-term unhealed wounds or incomplete healing fractures; 8. Imaging shows that the tumor has invaded the important blood vessels or the patient's tumor is highly likely to invade the important blood vessels during the treatment and cause fatal massive bleeding; 9. Patients with abnormal coagulation function and bleeding tendency (the INR must be within the normal range without anticoagulant or abnormal without clinical significance 14 days before histology); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Low-dose warfarin (1mg orally, once daily) or low-dose aspirin (not more than 100mg daily) is allowed for prophylaxis, provided that the international normalized ratio of prothrombin time (INR) is 1.5 or less; 10. Arteriovenous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except those who had recovered from venous thrombosis caused by intravenous catheterization during previous chemotherapy), and pulmonary embolism; 11. Urine routine indicated urinary protein =++ and confirmed 24-hour urinary protein quantification >1.0g; 12. Those who have a history of psychotropic drug abuse and are unable to abstain or have mental disorders; 13. Pleural effusion or abdominal effusion with clinical symptoms requiring clinical intervention; 14. Patients who do not follow medical advice, do not use drugs according to regulations, or have incomplete data, which may affect the judgment of efficacy or safety; 15. History of severe pulmonary function decline and interstitial pneumonia or pulmonary fibrosis; 16. Concomitant diseases that, in the investigator's judgment, seriously endanger the patient's safety or interfere with the patient's completion of the study. 17.There were other conditions that the researchers considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactJuan Wang
Affiliated Hospital of Nanjing Medical University
Outcome results
None listed