Colorectal cancer
Conditions
Interventions
Experimental group:Adebelizumab + bevacizumab (RAS- or BRAF-mutant) / cetuximab (RAS/BRAF wild-type) + 5-FU/LV ± oxaliplatin ± irinotecan
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient has a full understanding of this study, has voluntarily signed the informed consent form, demonstrates good compliance, and is willing to cooperate with follow-up; 2. Age >= 18 years and = 12 weeks; 5. Patients with histologically or pathologically confirmed colorectal adenocarcinoma; 6. Diagnostic records from PET/CT, CT, MRI, or intraoperative exploration indicate evidence of localized liver metastases (histological confirmation of liver metastases is not required); 7. MSS-type mCRC; 8. The patient has at least one measurable liver metastatic lesion (according to RECIST 1.1 criteria); 9. No prior chemotherapy for liver metastases; 10. The primary colorectal cancer site shows no symptoms of bleeding, obstruction, or perforation; the primary colorectal cancer site is resectable or has been resected; patients whose liver metastases were initially not resectable as R0 or whose residual liver volume is = 90 g/L; B. Absolute neutrophil count (ANC) >= 1.5 × 10?/L; C. Platelet count (PLT) >= 100 × 10?/L; (2) Biochemical tests must meet the following criteria: A. Total bilirubin (TBIL) 60 mL/min (Cockcroft-Gault formula); D. Urinalysis results showing urine protein (UPRO) = the lower limit of normal (50%); (4) Coagulation function: International Normalized Ratio (INR) <= 1.5×ULN and activated partial thromboplastin time (aPTT) <= 1.5×ULN; 12. Women of childbearing potential must agree to use effective contraception during the study and for 6 months after its completion; they must have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must not be breastfeeding; men must agree to use contraception during the study and for 6 months after its completion;
Exclusion criteria
Exclusion criteria: 1. Patients with allergies to the study drug; 2. Patients who have already received standard treatment for liver metastases from colorectal cancer; 3. Patients with a history of anticancer therapy or radiation therapy for any malignancy; 4. Patients currently receiving anticancer therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy; 5. Patients who have undergone major surgery unrelated to colorectal cancer within 4 weeks prior to enrollment, or who have not yet fully recovered from such surgery; 6. Patients with extrahepatic metastases, unresectable lymph node metastases (including portal vein lymph nodes), or recurrence of the primary tumor; 7. Patients in whom imaging shows tumor invasion of major blood vessels, or who, in the investigator’s judgment, are highly likely to develop tumor invasion of major blood vessels during the study, potentially leading to life-threatening hemorrhage; 8. Patients with a history of, or concurrent, other malignancies requiring active treatment within the past 5 years (excluding adequately treated conditions such as basal cell or squamous cell skin cancer with an estimated 5-year survival rate >90%, cervical carcinoma in situ, or breast carcinoma in situ); 9. Patients with active autoimmune diseases or immunodeficiency, or with a history of the following conditions, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.; 10. HIV-positive status, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation or allogeneic hematopoietic stem cell transplantation. Exceptions: Patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be enrolled in the study. Patients with type 1 diabetes whose blood glucose is controlled through an insulin regimen may participate in this study. 11. Patients currently receiving immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency) and who continue to use these medications within 2 weeks prior to enrollment; 12. Patients who have received high-dose systemic antibiotic therapy within the past 2 weeks; 13. Patients who have experienced an arterial or venous thromboembolic event within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, or pulmonary embolism; 14. Patients with clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Class >= 2 congestive heart failure; ventricular arrhythmias requiring medication (including QTc interval >= 450 ms in males and >= 470 ms in females); left ventricular ejection fraction (LVEF) = CTCAE 5.0 Grade 2 infection), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia; unexplained fever > 38.5°C occurring prior to the first dose; 16. Pleural effusion, pericardial effusion, or ascites with clinical symptoms and requiring frequent drainage as determined by the investigator; 17. Ci
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Safety of Drug Therapy;Disease control rate;R0 resection rate;Event-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYueming Sun
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed