colorectal cancer
Conditions
Interventions
Experimental group:Fruquintinib combined with single agent chemotherapy
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Patients must meet all of the following conditions in order to be enrolled in this study: 1. Age >= 18 years old; 2. Patients diagnosed with colon or rectal adenocarcinoma by pathology or cytology are excluded from all other histological types; 3. Accept at least two lines of standard treatment with imaging evidence to prove disease progression;For neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy), if disease progression occurs during treatment or within 6 months after discontinuation of treatment, it should be considered as first-line treatment (evaluated by researchers according to RECIST 1.1); 4. ECOG score: 0-2 points; 5. At least one CT measurable lesion according to RECIST 1.1 standard 6. Expected survival for at least 3 months. 7. The main organ function meets the following criteria within 7 days before treatment: (1) Hemoglobin (HB) >= 90 g/L;(2)Neutrophil absolute value (ANC) >= 1.5 × 10^9/L;(3) Platelet count (PLT) >= 100 × 10^9/L. 8. Biochemical examination must meet the following standards: (1) Total bilirubin (TBIL) = 60ml/min; 9. Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= lower limit of normal value (50%); 10. Patients of childbearing age (including female and male patients' female partners) must take effective contraceptive measures; 11. The subjects voluntarily joined this study and signed an informed consent form (ICF); 12: Those with good compliance are expected to be able to follow up on therapeutic effects and adverse reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1: If any of the following criteria are met, the study plan must be excluded: 1. Previously used other anti angiogenic small molecule TKI drugs, such as anlotinib, apatinib, sorafenib, regorafenib, etc 2. Pregnant or lactating women; 3. Patients who have participated in other clinical trials in the past but have not yet terminated the trial; 4. Subjects with a risk of gastrointestinal bleeding are not eligible for enrollment, such as those with active peptic ulcer lesions, accompanied by bleeding, or any other situation that may lead to gastrointestinal bleeding or perforation according to the researcher's judgment; 5. Patients with any severe and/or uncontrolled diseases, including: (1) Patients with poor blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg);(2) Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QTc >= 480ms), and >= grade 2 congestive heart failure (New York Heart Association (NYHA) classification);(3) Active or uncontrolled severe infections (>= CTC AE level 2 infection); (4) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; (5) Renal failure requires hemodialysis or peritoneal dialysis;(6) Two consecutive urine routine tests indicate urine protein >=++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0 g; (7) Suffering from mental illnesses, including epilepsy, dementia, severe depression, mania, etc. 6. Within 28 days before grouping, major surgical treatment, open biopsy, or obvious traumatic injury should be received (specific clinical evaluation should be combined); 7. Patients whose imaging shows that the tumor has invaded important blood vessels or who have been determined by the researcher to be highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies; 8. Patients with any signs of bleeding or medical history, regardless of severity; Within the 4 weeks prior to enrollment, patients with any bleeding or bleeding events >= CTCAE level 3 have unhealed wounds, ulcers, or fractures Individuals who have experienced arterial/venous thrombosis events within ; 9.6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism; 10. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 11. Patients with a serious history of allergies or allergic constitution; 12. Any disease or condition that affects drug absorption, or the inability to orally study the drug; 13;The researchers believe that there are other situations that are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS,progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactShujian Chang
Affiliated Hospital of Jiangnan University
Outcome results
None listed