Initially Unresectable Metastatic Colorectal Cancer
Conditions
Interventions
Experimental group:mXELOXIRI
Control group:FOLFOX/FOLFIRI Combined With Molecular Targeting Drug
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Diagnosis of metastatic colorectal cancer (mCRC), and assessed as initially unresectable mCRC by MDT. Initially unresectable mCRC is defined by meeting any of the following criteria: 1) Metastatic sites >=5, and number of visceral organ >=1; 2) Unable to perform R0 resection; 3) The residual liver volume is expected to be insufficient after resection; 4) After the resection, all three hepatic veins could not be preserved, and the blood flow and bile duct of the residual liver could not be preserved, and the adjacent two liver segments could not be preserved; 3. ECOG status 0 to 1; 4. Expected survival >=12 weeks; 5. Absolute neutrophil count (ANC) >=3.0 x10^9/L, Hemoglobin (Hb) >=8g/dL, Platelet count >=100 x 10^9/L (subject to the normal values from clinical trials center); 6. Prothrombin time (PT) or activated partial thrombin time (APTT) =50 mL/min will be excluded); 8. AST and ALT<=2.5 ULN, serum total bilirubin <=1.5 ULN; ALT and AST <=5 ULN, Serum total bilirubin <=3 ULN in patients with liver metastasis; 9. Women of reproductive age must agree to use effective contraceptive measures during the study drug use; 10. Fully understand the study and sign informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Previously received chemotherapy for locally advanced or metastatic cancer focus (patients who have previously received adjuvant therapy and/or neoadjuvant therapy, if the interval between the end of therapy and first recurrence/metastasis is more than 12 months, can be included); (2) Assessed as initially resectable mCRC by MDT; (3) Have received surgery (except diagnostic biopsy) and radiotherapy within 3 weeks; (4) Have received any experimental therapy (such as take part in another clinical study) within 4 weeks before treatment; (5) Have received immunotherapy, chemotherapy, radiotherapy (except palliative radiotherapy), or hormonotherapy, which are not included in study protocol; (6) Known or suspected brain metastases; (7) Pregnant and nursing women; (8) Severe uncontrolled systemic disease, for example, severe uncontrolled active infection; (9) Known allergy to any study drug; (10) Any indication of contraindications to chemotherapy; (11) Have had other malignant tumors within the past 5 years, cervical carcinoma in situ or basal cell carcinoma of the skin are excluded; (12) The investigator judges that patients can not finish the clinical study due to medical, social, or psychological reasons, or can not sign a valid informed consent; (13) Patients with parenchymal organ transplantation who need to receive immunosuppressive therapy; (14) Known human immunodeficiency virus (HIV) infection, or known to be HIV seropositive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;R0 resection rate;Overall survival; | — |
Countries
China
Contacts
Public ContactWeiqin Jiang
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed