Colorectal cancer
Conditions
Interventions
experimental group:Fuquinitinib combined sintilimab and SBRT
Sponsors
Ningbo No.2 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Understand the research steps and content, and voluntarily sign a written informed consent; 2. Subjects aged 18-80 years; ECOG PS: 0-1; Expected survival period > 3 months; 3. Histologically confirmed adenocarcinoma of advanced colorectal cancer who had failed standard first - and second-line treatment; 4. Patients who can provide previously stored tumor tissue specimens or conduct biopsy to collect tumor lesion tissue for detection of k-ras, N-ras, BRAF, MSI/MMR expression; 5. At least one measurable lesion according to RECIST 1.1; 6. Good organ function(14),: (1) >= 80 g/L;(ANC) >= 1.5 x 10^9/L; >= 80 x 10^9/L; (2) ALTAST = 50 mL/min; (5) >= 30 g/L; (6) (INR)(PT)(APTT) = 50%; 7. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot beconfirmed as negative, a serum pregnancy test will be required. A female of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should beused starting from trial screening and must be continued throughout the study.
Exclusion criteria
Exclusion criteria: 1. Combined disease and history: (1) Patients with malignant disease other than the treated tumor of the study within 3 years(exceptions include: cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]); (2) Having multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); (3) Gastrointestinal bleeding or perforation was occurred or tended to occur during the first 4 weeks of enrollment; (4) Patients with ulcerative colitis, Crohn's disease and active inflammatory bowel disease within the first 4 weeks of enrollment; (5) Uncontrolled pleural effusion, ascites, and moderate or above pericardial effusion requiring repeated drainage; (6) Unmitigated toxic reactions >= grade 1 according to CTCAE due to any prior treatment, excluding alopecia; (7) Received major surgical treatment, open biopsy, or significant traumatic injury (except gastroenteroscopic tissue biopsy) within 28 days prior to enrollment; (8) Patients who developed hematemesis, hematochezia, or any bleeding event >= grade 3 according to CTCAE within 3 months prior to screening, or who had any signs of bleeding or had a history that the investigator determined was not suitable for enrollment, regardless of severity; (9) The presence of open wounds, ulcers or fractures; (10) Experienced arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months; (11) A history of psychotropic substance abuse and inability to abstain; (12) Subjects with any severe and/or uncontrolled medical condition: 1) Uncontrolled hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg after standard antihypertensive treatment); 2) Suffering from unstable angina pectoris/cardiogenic chest pain >= 2; Myocardial infarction occurred within = grade 2 (new york Heart Association (NYHA) classification); Restrictive heart disease; Grade >= 2 atrioventricular block, arrhythmia that can't be stably controlled by drugs [including QTc >= 450 ms (male) and QTc >= 470 ms (female)] and arrhythmia that may have potential influence on experimental treatment; 3) Active infection (>= CTCAE grade 2 infection); 4) Decompensated cirrhosis and active hepatitis; (active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA positive (> 2500 copies /ml or > 500 IU/ml); Hepatitis C reference: HCV antibody is positive, and the detection value of HCV virus titer exceeds the upper limit of normal value); Note: those who meet the conditions for joining the group. Subjects with positive HBsAg or core antibody and patients with hepatitis C need continuous antiviral treatment to prevent virus activation); 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) Have a history of immunodeficiency diseases, including HIV-positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 7) Poor diabetes control (fasting blood glucose (FBG) > 10 mmol/L); 8) The routine urine test indicates that the urine protein is >= ++,and it is confirmed that the 24-hour proteinuria quantity is > 1.0 g; 9) Those who have a clear history of neurological or mental disorders,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival assessed by the investigator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Objective response rate, ORR;Disease Control Rate, DCR;Duration of Response, DOR; | — |
Countries
China
Contacts
Public ContactZhang Chen; Wang Yi
Ningbo No.2 Hospital
Outcome results
None listed