Colorectal cancer
Conditions
Interventions
Single-arm:Adelbelimab: Intravenous infusion, 1200 mg dose, D1, Q2W
Cetuximab: Intravenous infusion, 500 mg/m^2 dose, D1, Q2W (RAS/BRAF wild-type with primary lesion in left-sided colon)
Bevacizumab: IV infusion, 5 mg/kg, D1, Q2W (RAS/BRAF wild-type with primary lesio
Chemotherapy: Liposomal irinotecan 60 mg/m^2 d1
LV 400 mg/m^2 on Day 1
5-FU 400 mg/m^2 intravenous bolus on Day 1 followed by 1200 mg/m^2 × 2 days continuous intravenous infusion (total dose 2400 mg/m^2 infused over 46-48 hours).
All subjects received up to 12 cycles of
Sponsors
Shanxi Hospital of Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand this study and voluntarily sign the informed consent form, with good compliance and follow-up; . Age = 18 years old and = 12 weeks; 5. Patients with histologically or pathologically confirmed adenocarcinoma of the colon and rectum; 6. Evidence of liver metastasis was recorded in PET/CT scan, CT scan, MRI, or intraoperative exploration (histological confirmation of liver metastasis is not required); 7. Patients have at least one measurable lesion in the liver metastasis (according to RECIST 1.1 criteria); 8. Patients with primary colorectal cancer without bleeding obstruction symptoms, and without perforation; primary colorectal cancer can be or has been radically resected, and patients with liver metastases who cannot be R0section initially or residual liver volume = 90 g/L; B. Absolute neutroph count (ANC) >=1.5 × 10^9/L; C. Platelet count (PLT) >= 100 ×10^9/L; (2) Biochemical examination needs to meet the following criteria: A. Total bilirubin (TBIL) 60 ml/min (Cockcroft-Gault formula); D. Urinalysis shows urine protein (UPRO) = the lower limit of normal (50%); (4) Coagulation function: international normalized ratio (R) <= 1.5 × ULN and activated partial thromboplastin time <= 1.5 × ULN; 11. File women should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study; a negative serum or urine pregnancy test within 7 before study enrollment, and must be non-lactating patients; males should agree to use contraceptive measures during the study period and within 6 months after the end of the.
Exclusion criteria
Exclusion criteria: 1. Subjects who are allergic to study drug; 2. Patients who have been treated standard therapy for colorectal cancer liver metastasis; 3. Subjects who are currently participating in other clinical trials of anticancer therapies, including endocrine therapy bisphosphonates, or immunotherapy; 4. Subjects who have undergone a major surgery not related to colorectal cancer within 4 weeks of study entry or subjects who have not yet recovered completely from such surgery; 5. Subjects with extrahepatic metastases, non-resectable lymph node metastases (including vein lymph node metastases), and primary tumor recurrence; 6. Subjects with tumor involvement of major blood vessels on imaging or who, in the opinion of the investigator, highly likely to invade major blood vessels during the study period and cause life-threatening hemorrhage; 7. Subjects with other malignancies requiring active treatment within years, either previously or currently, other than those that have been adequately treated and are not expected to result in death within 5 years (e.g., basal cell squamous cell skin cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast); 8. Subjects with active autoimmune disease or immunodef, or a history of such diseases, including but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, rheumatoid arthritis, inflammatory disease, pituitary inflammation, vasculitis, nephritis, etc.); 9. Subjects who are HIV positive or have other acquired, congenital deficiencies, or a history of organ transplantation, allogeneic hematopoietic stem cell transplantation. The following exceptions are allowed: subjects with a history of auto thyroid disease but are receiving thyroid hormone replacement therapy may be enrolled in the study. Patients with type 1 diabetes mellitus controlled with insulin regimen may participate in this study. 10. Subjects who are currently using immunosuppressants, or systemic corticosteroid therapy for the purpose of immunosuppression (dosage > 10/day prednisone or other equivalent efficacy steroids) and still continuing within 2 weeks of study entry; 11. Subjects who have used high-dose antibiotics systemic treatment within 2 weeks; 12. Subjects with clinically significant cardiovascular disease, including but not limited to myocardial infarction within 6 months before entry, severe/unstable angina, or coronary artery bypass grafting; congestive heart failure New York Heart Association (NYHA) grade >= 2; ventricularhythmias requiring drug treatment (including QTc interval male >= 450 ms, female >= 470 ms); left ventricular ejection fraction (LVEF 38.5°C occurring before the first dose; 14.jects with clinically symptomatic pleural effusion, pericardial effusion, or ascites that, in the opinion of the investigator, require frequent drainage; 15 Subjects with cirrhosis, active hepatitis; HBV reference: HBsAg positive, and HBV DNA above the upper limit of normal (1000 copiesml or 500 IU/ml); subjects with a history of hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence ofitis B core antibody [HBcAb] and the absence of HBsAg, and with normal HBV DNA values at the screening period may be included; HCV reference: H antibody positive, and HCV vir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Depth of Response;early tumor shrinkage;R0 resection rate;Progression-free survival;Overall Survival;Adverse Event (AE)/Serious Adverse Event (SAE); | — |
Countries
China
Contacts
Public ContactYang Wenhui, Liu Haiyi
The Cancer Hospital of the Chinese Academy of Medical Sciences, Shanxi Branch (Shanxi Provincial Cancer Hospital)
Outcome results
None listed