Colorectal cancer
Conditions
Interventions
Test group:Surufatinib+tislelizumab
Sponsors
Anhui Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years old; 2. Patients with pathologically or cytologically confirmed adenocarcinoma of the colon or rectum, excluding all other histological types; 3. Failure of prior treatment with furquintinib and/or TAS102, regorafenib and/or TAS-102, subject will also receive chemotherapy based on fluorouracil, oxaliplatin, and irinotecan;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: 0-1; 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) Hemoglobin (HB) =90 g/L; (2) Absolute value of neutrophil (ANC) =1.5×109/L; (3) Platelet (PLT) =100×109/L 8. Biochemical tests should meet the following standards: (1) Total bilirubin (TBIL) =1.5 times normal upper limit (ULN); (2) ALANine aminotransferase (ALT) and aspartate aminotransferase AST=2.5×ULN, if accompanied by liver metastasis, ALT and AST=5×ULN; (3) serum creatinine (Cr) =1.5×ULN or creatinine clearance (CCr)=60ml/min; 9. Patients of reproductive age (including female and female partners of male patients) must use effective birth control measures; 10. Subjects voluntarily participate in the study and sign the informed consent (ICF); 11.It is expected that patients with good compliance will be able to follow up the efficacy and adverse reactions according to protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients were previously treated with surufatinib capsules; 2. Patients previously treated with tirelizumab; 3. In addition to furquintinib and regorafenib, other anti-angiogenic small molecule TKI drugs were used previously, such as anlotinib, apatinib, sorafenib, etc.; 4. Patients with MSI-H/dMMR confirmed by immunohistochemistry and/or PCR; 5. Pregnant or lactating women; 6. Patients who have participated in other clinical trials in the past but have not terminated the trials; 7. Subjects at risk of gastrointestinal bleeding should not be enrolled if they have active ulcer lesions associated with bleeding, or any other condition that, in the investigator's judgment, may result in gastrointestinal bleeding or perforation; 8. 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>=480ms) and grade 2 congestive heart failure (NYHA classification); (3) Active or uncontrolled severe infection (>=CTC AE 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 > 1.0g; (7) Suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc. 9. Major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping (combined with clinical evaluation); 10. 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.; 11. Patients whose imaging shows that the tumor has invaded the periphery of important blood vessels or who are judged by the investigator to be highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 12. 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; 13. Arteriovenous/venous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, occurred within 6 months; 14. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 15. Patients with severe allergic history or allergic constitution; 16. Any disease or condition that affects absorption of the drug, or inability to take the study drug orally; 17. There were other conditions that the researcher 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;Security; | — |
Countries
China
Contacts
Public ContactHe Yifu
Anhui Cancer Hospital
Outcome results
None listed