Colorectal Cancer Liver Metastases
Conditions
Interventions
experimental group:HAIC Combined With Regorafenib and Nivolumab
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged18-75 years; 2. pMMR/MSS Colorectal Cancer Liver Metastases Patients confirmed by histology/cytology; 3. pMMR/MSS Colorectal Cancer Liver Metastases Patients who can not be treated with systemic chemotherapy, or have failed systemic chemotherapy; 4. PS score: = 1.5x10^9/L; (2) Platelet count (platelet, PLT) >= 100x10^9/L; (3) Hemoglobin content (hemoglobin, HGB) >= 9.0 g/dL; (4) Serum total bilirubin (total bilirubin, TBIL) = 28 g/L; (8) Alkaline phosphatase (ALP) = 50 mL/min (Cockcroft-Gault formula); (10) Urine routine test results show urine protein = 2+, 24-hour urine collection and 24-hour urine protein quantitative <1g should be performed; (11) International normalized ratio (INR) or activated partial thromboplastin time (APTT) <= 1.5 times ULN. 8. Female patients of childbearing age or male patients whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the last medication; 9. Be able to sign written informed consent and be able to comply with the visits and related procedures stipulated in the plan.
Exclusion criteria
Exclusion criteria: 1.History of contrast agent allergy; 2.Patients with known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation; 3.There is any active autoimmune disease or a history of autoimmune disease; 4.PS score:= 2 points; 5.Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), HBV or HCV infection; 6.Diagnosed with any other malignant tumors (Includes ampullary carcinoma/small cell carcinoma/neuroendocrine tumors/lymphoma/sarcoma/mixed tumor histology and/or mucinous cystic neoplasm); 7.Any life-threatening bleeding event occurred within 6 months before enrollment; 8.Symptomatic congestive heart failure (Class II-IV of the New York Heart Association), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or QTc> 500ms corrected during screening, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy; 9.Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases; 10.Severe infections in active phase or poor clinical control or severe infections within 4 weeks before enrollment; 11.Have used immunosuppressive drugs within 4 weeks before enrollment (excluding local glucocorticoids or physiological doses of systemic glucocorticoids, ie <10mg/day, prednisone or equivalent doses of other glucocorticoids); 12.Women during pregnancy and breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Safety;The incidence of drug-related adverse events;Incidence of adverse events;Incidence of death;Incidence of adverse events leading to treatment cessation and early withdrawal from the study; | — |
Countries
China
Contacts
Public ContactLi Xiao
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed