Colorectal cancer liver metastases
Conditions
Interventions
Group A:Bevacizumab 7.5mg/kg, administered on the first day, intravenous injection
oxaliplatin 130mg/m^2 administered on the first day, intravenous injection
capecitabine 1g/m^2 twice a day, orally, continuously 14 days, 1 week off, 3 weeks for a cycle
Group B:Bevacizumab 7.5mg/kg, administered on the first day, intravenous injection
capecitabine 1g/m^2 twice a day, orally, continuously 14 days, 1 week off
sintilimab 200mg, administered on the first day, intravenous injection,3 weeks for a cycle.
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Before implementing any trial-related procedures, written informed consent should be signed; 2. =18 and =79 years old, male or female; 3. Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma (extrahepatic metastasis does not need to be ruled out); 4. Have not received first-line systemic therapy for liver metastases (such as targeted therapy, immunotherapy, systemic chemotherapy); 5. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging; 6. The multidisciplinary team (MDT) confirmed that the liver metastases were initially unresectable (unresectable criteria for liver metastases: the liver cannot reach tumor-free status through surgical resection or localized treatment such as combined ablation/stereotactic radiotherapy, or the residual liver volume is less than 40%) , with/without locally treatable extrahepatic metastases; 7. The genetic mutation test showed RAS mutation or RAS wild-type in the right colon, MSS; 8. The general physical condition is good (ECOG score 0-1); 9. Life expectancy of more than 3 months; 10. There is no obvious symptoms of primary bleeding, obstruction and other indications for emergency surgery; 11. Cannot participate in other clinical trials at the same time; 12. Sufficient organ function, the subject needs to meet the following laboratory indicators: 1) In the case of no use of granulocyte colony-stimulating factor in the past 14 days, the absolute value of neutrophils (ANC) = 1.5×10^9/L; 2) Platelets = 75×10^9/L without blood transfusion in the past 14 days; 3) Hemoglobin>70g/L without blood transfusion or use of erythropoietin in the past 14 days; 4) Total bilirubin = 1.5 times the upper limit of normal (ULN); serum albumin = 28.0 g/L 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are =2.5×ULN (subjects with liver metastases are allowed ALT or AST =5×ULN); 6) Serum creatinine = 1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) = 60 ml/min; 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5×ULN; 13. Female subjects with reproductive potential or male subjects with reproductive potential partners agree to use high-efficiency contraceptive measures (annual failure rate less than 1%) from 7 days before the first dose until 24 weeks after the dose. 14. Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days before the first dose. 15. The subjects are able and willing to comply with the visits, treatment plans, laboratory tests and other research-related procedures stipulated in the research protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot tolerate systemic chemotherapy or surgery; 2. Liver metastases occurred during or within 6 months after the primary tumor received oxaliplatin adjuvant chemotherapy; 3. Have undergone major surgical operations within 6 weeks before the start of drug administration or are expected to undergo major surgical treatment during the study period, or have severe traumatic injuries, fractures or ulcers, or long-term unhealed wounds; 4. Suffering from myocardial infarction, severe or unstable angina pectoris, coronary artery bypass graft surgery, heart failure (New York Heart Association functional class III-IV) within 3 months before the start of drug administration; 5. Patients who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.); 6. At the same time or previously accompanied by other malignant tumors, and the expected survival time is less than 12 months. 7. Patients with previous autoimmune diseases, who have received allogeneic stem cells or solid organ transplantation and cannot tolerate immunotherapy; 8. Have a history of moderate to severe allergic reactions, hypersensitivity reactions, and intolerance to known antibody drugs; 9. Significant clinically significant bleeding symptoms or clear bleeding tendency occurred within 3 months before the start of administration, such as gastrointestinal bleeding, gastroesophageal varices, bleeding gastric ulcer, etc., with a history of hematochezia, hematemesis, and hemoptysis; 10. A large amount of abdominal/pleural effusion or pericardial effusion accompanied by clinical symptoms or requiring symptomatic treatment; 11. There was primary obstruction perforation or intra-abdominal infection within 3 months before the start of study treatment, and had not been treated. 12. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 13. People who are known to be allergic to the active ingredients or excipients of the drug in this study; 14. Other conditions that the researchers think are not suitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical conversion rate;progression-free survival;overall survival;Treatment related adverse events; | — |
Countries
China
Contacts
Public ContactBaocai Xing
Hepatopancreatobiliary Surgery Department I, Peking University Cancer Hospital & Institute
Outcome results
None listed