Colorectal Cancer, Liver Metastases
Conditions
Brief summary
Evaluation of tislellimab combined with XELOX and bevacizumab or tislelizumab combined with FOLFOX and cetuximab regimen in patients with liver metastases from colorectal cancer Rate and R0 resection rate and safety.
Interventions
DRUGExperimental drug
Tilelizumab combined with XELOX and bevacizumab or tislelizumab combined with FOLFOX and cetuximab
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
3.1 Entry criteria: 1. Male or female, age ≥18 years old, ≤75 years old 2. Liver metastases of colorectal adenocarcinoma confirmed by histology, liver metastases are initially unresectable 3. RAS gene mutation or wild type, BRAF wild type, MSS type 4. ECOG physical status is 0 to 1 points 5. Life expectancy is at least 12 weeks 6. Absolute neutrophil count (ANC)\>1.5×109/L, hemoglobin\>8g/dL and platelets\>100×109/L (based on the normal value of the clinical trial center) 7. Prothrombin time (PT) \<1.5 times the upper limit of normal and normal thromboplastin time (APTT) \<1.5 times the upper limit of normal 8. Laboratory examination, serum creatinine is less than or equal to 1.5 times the upper limit of the reference range of normal value (if serum creatinine rises, 24-hour urine must be collected, except for those with 24-hour creatinine clearance\> 50ml/min) 9. When there is no liver metastasis, ALT or AST is less than or equal to 2.5 times the upper limit of the normal value reference range, and serum total bilirubin is less than or equal to 1.5 times the upper limit of the normal value reference range; for patients with liver metastases, ALT or AST is less than Or equal to 5 times the upper limit of the reference range of normal values, and serum total bilirubin is less than or equal to 3 times the upper limit of the reference range of normal values 10. Women of childbearing age must be willing to adopt adequate contraceptive measures during study drug treatment 11. Signed informed consent 12. According to the definition of RECIST 1.1, the investigator determines that the patient has a measurable disease. Tumor lesions located in the area of previous radiotherapy are considered measurable if they are confirmed to have progressed.
Exclusion criteria
3.2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rates | 3 months | Conversion rates based on RECIST1.1 |
| R0 resection rate | 3 months | R0 resection rate based on RECIST1.1 |
| Drug Safety | 12 months | Drug safety assessed by CTCAE v4.0; Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 3 months | objective response rate based on RECIST1.1 |
| DCR | through study completion，an average of 2 years | Disease control rate % based on RECIST1.1 |
| PFS | through study completion，an average of 2 years | Progression-Free Survival % |
| OS | through study completion，an average of 3 years | Overall survival % |
Countries
China
Contacts
Primary ContactYing Yuan, MD
Backup ContactXuefeng Fang, phD
Outcome results
None listed