colorectal cancer
Conditions
Interventions
Group 1 :surufatinib + sintilimab
Sponsors
Anqing Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years old; 2. Advanced colorectal cancer confirmed by histopathology or cytology; 3. Recurrent or metastatic colorectal cancer that has failed or cannot be tolerated by previous systemic standard therapy; The definition of failure was: toxic and side effects were not tolerated, disease progression during treatment or recurrence after treatment; Intolerance is defined as grade IV hematological toxicity (grade III and above thrombocytopenia), grade III or above non-hematological toxicity; 4. ECOG score: 0-2; 5. Have at least one measurable lesion on CT, according to RECIST 1.1; 6. Expect to survive for at least 3 months. 7. Major organ functions within 7 days before treatment meet the following criteria: (1) Blood routine examination standards (no blood transfusion within 14 days) : (2) Hemoglobin (HB) >= 90 g/L; (3) Absolute value of neutrophil (ANC) >= 1.5 x 10^9/L; (4) Platelet (PLT) >= 100 x 10^9/L. 8. Biochemical tests should meet the following standards: (1) Total bilirubin (TBIL) = 60 ml/min; 9. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= normal lower limit (50%). 10. Patients of reproductive age (including female and female partners of male patients) must use effective birth control measures; 11. The subjects voluntarily participated in the study and signed the informed consent (ICF); 12. It is expected that patients with good compliance can follow up the efficacy and adverse reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients were previously treated with surufatinib capsules; 2. Prior use of anti-PD-1 or anti-PD-L1 /L2 antibodies or anti-cytotoxic T lymphocyte associated antigen (CTLA-4) antibodies; 3. Pregnant or lactating women; 4. Patients who have participated in other clinical trials in the past but have not terminated the trials; 5. Subjects with risk of gastrointestinal bleeding should not be enrolled, with active ulcer lesions accompanied by bleeding; 6. Patients with any severe and/or uncontrolled disease, including: (1) Patients with poor blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg); (2) Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc >= 480 ms) and grade 2 congestive heart failure (NYHA classification); (3) Active or uncontrolled severe infection ( >= CTCAE grade 2 infection); (4) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (5) Renal failure requiring hemodialysis or peritoneal dialysis; (6) Urine protein >= ++ indicated by two consecutive urine routine tests, and the 24-hour urine protein level was confirmed to be > 1.0 g (7) Suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc. 7. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping (combined with clinical evaluation); 8. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc.; 9. Patients whose imaging shows that the tumor has invaded the perivascular area of important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the subsequent study period; 10. Patients with any physical signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event >= CTCAE grade 3 within 4 weeks prior to enrollment had unhealed wounds, ulcers or fractures; 11. Patients who have experienced arteriovenous or venous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 12. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 13. Patients with severe allergic history or allergic constitution; 14. Any disease or condition that affects absorption of the drug, or inability to take the study drug orally; 15. There were other conditions that the investigator considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactLi Chenghui
Anqing Municipal Hospital
Outcome results
None listed