Metastatic colorectal adenocarcinoma
Conditions
Interventions
Active Comparator:FOLFOX plus targeted therapy
Experimental:NALIRIFOX plus targeted therapy
Sponsors
Zhongshan Hospital, Fudan University
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 adenocarcinoma (metastatic: stage IV according to the UICC TNM staging system [2017 8th edition]); 3. No systemic anti-tumor therapy (including but not limited to systemic chemotherapy, molecularly targeted drug therapy, immunotherapy, biological therapy, and other investigational therapeutic drugs) in the stage of metastatic disease that cannot be surgically resected; 4. Patients who have received neoadjuvant or adjuvant therapy in the past must have an interval of 12 months between the first discovery of progression of the disease and the date of the last dose of neoadjuvant or adjuvant therapy= 5. At least 1 measurable target lesion that can be evaluated according to RECIST v1.1 criteria; 6. ECOG score is 0~1; 7. Good bone marrow and organ function: (1) Neutrophils (ANC) >=1.5×10^9/L, platelets (PLT) >=100×10^9/L, hemoglobin (Hb) >=90g/L, white blood cells (WBC) >=3.0×10^9/L, albumin (ALB) >=30 g/L with no bleeding tendency; (2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) were all =60 ml/min (calculated according to Cockroft-Gault); 8. Able to understand the situation of this study, patients and/or guardians voluntarily agree to participate in this study and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients with known MSI-H or dMMR who were evaluated by investigators as suitable for treatment with immune checkpoint inhibitors. 2.Patients allergic to the investigational drug and its excipients; 3.Underweight (body mass index [BMI]<18.5 kg/m^2; 4.Known or suspected central nervous system metastasis; 5.Received irinotecan before enrollment; 6.Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment; 7.Previous treatment-related toxicity didn’t return to NCI-CTCAE v5.0 class I or below. 8.The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn’t be discontinued or were not discontinued within 2 weeks prior to enrollment; 9.Serious gastrointestinal disorders; 10.Interstitial lung disease; 11.Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding); 12.Patients with fluid accumulation that couldn’t reach a stable state and small amount of pleural effusion or ascites on imaging without clinical symptoms could be enrolled; 13.Intestinal obstruction, or a risk of intestinal obstruction in the short term; 14.Gastrointestinal perforation, intraperitoneal abscess, and fistula; 15.Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc; 16.Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer; 17.Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding; 18.The researchers didn’t consider it appropriate to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 18 month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection;Safety;Disease control rate;Surgical resection rate;Overall survival;Objective response rate;Progression free survival; | — |
Countries
China
Contacts
Public ContactTianshu LIU
Zhongshan Hospital, Fudan University
Outcome results
None listed