RAS mutation, MSS metastatic colorectal cancer
Conditions
Interventions
experimental group:Irinotecan liposomes combined with capecitabine + Sindilizumab +/- bevacizumab
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Patients with histopathologically confirmed, inoperable metastatic colorectal cancer (metastatic: Stage IV according to the UICC/AJCC TNM staging system [8th edition 2017]); 3. Known RAS mutation and BRAF wild type; 4. Known to be pMMR or MSS type; 5. have not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, molecular targeted drug therapy, immunotherapy, biotherapy and other investigational therapeutic drugs) after being diagnosed with metastatic bowel cancer; 6. For subjects who have previously received neoadjuvant or adjuvant therapy, the date of disease progression first detected must be at least 6 months away from the date of last administration of neoadjuvant or adjuvant therapy; 7. ECOG score 0~1; 8. The presence of at least one measurable target lesion (assessed according to RECIST v1.1); 9. Good bone marrow and organ function: (1) Neutrophils (ANC) >=1.5×10^9/L, platelets (PLT) >=100×10^9/L, hemoglobin (Hb) >=80 g/L, albumin (ALB) >=30 g/L, white blood cells (WBC) >=3.0×10^9/L, and no bleeding tendency; (2) AST, ALT and alkaline phosphatase (ALP) were all =40 ml/min (calculated according to Cockroft-Gault); 10. The patient can understand the situation of the study, and the patient and/or legal representative voluntarily agree to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known or suspected central nervous system metastasis; 2. Received treatment with irinotecan or irinotecan liposome before enrollment; 3. Received surgery within 5 weeks before enrollment and other anti-tumor treatments (including chemotherapy, radiotherapy, study treatment, etc.) within 4 weeks before enrollment; 4. Toxicity related to previous treatments has not recovered to grade I or lower according to NCI-CTCAE v5.0 (except for alopecia and peripheral neuropathy); 5. Unable to discontinue or did not discontinue strong inhibitors or inducers of CYP3A, CYP2C8, and UGT1A1 within 2 weeks before enrollment (such as anticonvulsants [phenytoin, phenobarbital, or carbamazepine], rifampicin, rifabutin, St. John's Wort, grapefruit juice, clarithromycin, itraconazole, lopinavir, nevirapine, nelfinavir, ritonavir, saquinavir, tipranavir, voriconazole, atazanavir, gefitinib, indinavir, etc.); 6. Existence of severe gastrointestinal dysfunction (such as inflammation or diarrhea greater than grade I of NCI-CTCAE v5.0) or presence of gastrointestinal perforation, intra-abdominal abscess, and fistula; 7. Existence of intestinal obstruction or symptoms and signs of intestinal obstruction, or history of intestinal stent implantation that has not been removed by the screening period; 8. Presence of interstitial lung disease, except for interstitial changes shown only by imaging; 9. Presence of arterial embolism, severe bleeding (except for bleeding caused by surgery), or existing embolism, severe bleeding tendency within 6 months before enrollment; 10. Existence of unstable third-space effusion (such as large pleural effusion, ascites, pericardial effusion) that cannot be reached (such as a large amount of ascites, without clinical symptoms, can be enrolled); 11. Any serious or uncontrollable systemic diseases, including uncontrollable hypertension (defined as systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg after standardized antihypertensive drug treatment), heart disease, active bleeding, active viral infections (including hepatitis B, hepatitis C [if hepatitis B surface antigen or core antibody is positive, add test for HBV DNA, hepatitis B virus DNA exceeding the maximum value limit of this center needs to be excluded; if hepatitis C antibody is positive, add test for HCV RNA, hepatitis C virus RNA exceeding the maximum value limit of this center needs to be excluded], human immunodeficiency virus [HIV] infection, etc.); 12. History of other malignant tumors within 5 years before or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer; 13. Pregnant or lactating female patients, and patients of childbearing age who refuse to accept contraceptive measures; 14. Patients deemed unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RECIST 1.1 standard assessment of objective response rate (ORR) and adverse events assessed according to CTCAE 5.0.; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactJin Yongdong
Sichuan Cancer Hospital
Outcome results
None listed