Patients with unresectable advanced metastatic colorectal cancer (MSS or MSI-L/pMMR, RAS and BRAF wild-type) who have failed at least two lines of prior chemotherapy.
Conditions
Interventions
Experimental group:Patients enrolled in the study received irinotecan liposome II in combination with cetuximab.
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18-75, open to all genders; 2. Histologically or cytologically confirmed metastatic colorectal cancer, stage IV; 3. MSS or MSI-L/pMMR, RAS and BRAF wild-type patients; 4. At least one measurable target lesion is present according to RECIST v1.1 criteria. 5. Progression on at least second-line therapy according to standard protocols, or intolerance to standard treatment regimens; 6. Metastatic lesions are not suitable for surgical or interventional treatment. 7. ECOG Performance Status 0-2; 8. Expected survival time greater than 3 months; 9. Bone marrow function is adequate, with laboratory values meeting the following criteria within 7 days prior to enrollment: Neutrophil count (ANC) >=1.5 × 10?/L, Platelet count (PLT) >= 100 × 10?/L, Hemoglobin (Hb) >= 90 g/L, White blood cell count (WBC) >= 3.0 × 10?/L, and no bleeding tendency. 10. Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) all = 40 mL/min (calculated using Cockroft-Gault formula); Urinalysis results showing proteinuria < 2+; 12. Coagulation function: International Normalized Ratio (INR) <= 1.5 and Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN. 13. Women who are not pregnant or breastfeeding; Women of childbearing potential and men must use effective contraception during the study period and for 6 months after the end of study treatment. 14. The patient demonstrated good compliance, understood the study protocol, and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of other malignant tumors within the past 5 years (excluding cured carcinoma in situ and basal cell carcinoma of the skin); 2. Undergone surgery within 5 weeks prior to enrollment or received other antitumor treatments (including chemotherapy, radiotherapy, investigational therapy, etc.) within 4 weeks prior to enrollment. 3. Grade 3 or 4 peripheral neuropathy is present. 4. Uncontrollable systemic infections (viral, bacterial, and fungal); 5. Individuals with a history of hypersensitivity to irinotecan liposome or cetuximab, or to any component of the aforementioned products. 6. Strong inhibitors or inducers of CYP3A, CYP2C8, and UGT1A1 (anticonvulsants [phenytoin, phenobarbital, or carbamazepine], rifampin, rifabutin, St. John's Wort, grapefruit juice, clarithromycin, itraconazole, lopinavir, nifedipine, ritonavir, saquinavir, telaprevir, voriconazole, atazanavir, gemfibrozil, indinavir, etc.); 7. Previous treatment-related toxicities have not recovered to NCI-CTCAE v5.0 Grade I or below (except for alopecia and peripheral neuropathy). 8. Severe gastrointestinal dysfunction (e.g., inflammation or diarrhea exceeding Grade 1 per NCI-CTCAE v5.0) or presence of gastrointestinal perforation, intra-abdominal abscess, and fistula; 9. Presence of intestinal obstruction or symptoms and signs indicative of intestinal obstruction, or prior intestinal stent implantation with the stent still in place at the time of screening. 10. Patients with third-space fluid accumulation (e.g., massive pleural effusion, ascites, pericardial effusion) that cannot achieve a stable state (requiring no intervention after drainage tube removal) may be enrolled if imaging shows only minimal ascites without clinical symptoms. 11. Stroke or transient ischemic attack occurring within 12 months prior to enrollment; 12. Subjects with poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within the past year. 13. A history of clearly defined neurological or psychiatric disorders, including epilepsy or dementia; 14. Subjects with active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL) or hepatitis C (HCV antibody positive, or HCV RNA above the lower limit of detection of the analytical method); 15. Individuals known to have acquired immunodeficiency syndrome (AIDS) or a positive HIV test result, or those with active syphilis infection. 16. Any severe or uncontrolled systemic disease, including uncontrolled hypertension (defined as systolic blood pressure =140 mmHg and/or diastolic blood pressure >=90 mmHg despite standardized antihypertensive therapy), active bleeding, active viral infections (including hepatitis B, hepatitis C [if either hepatitis B surface antigen or core antibody is positive, add HBV DNA testing; exclusion required if hepatitis B virus DNA exceeds the center's maximum upper limit]; if HCV antibody is positive, HCV RNA should be tested; exclusion required if HCV RNA exceeds the maximum upper limit of this center); human immunodeficiency virus (HIV) infection, etc. 17. Subjects who had participated in other clinical trials within the 4 weeks prior to obtaining informed consent; 18. Patients deemed unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Overall survival, OS;Progression free survival, PFS;Drug Safety; | — |
Countries
China
Contacts
Public ContactXiao Liang
Shenzhen Second People's Hospital
Outcome results
None listed