colorectal cancer liver metastases
Conditions
Interventions
Experimental Group:Huaier Granules + CapeOx 3-week regimen
Control Group:CapeOx 3-week regimen
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signing informed consent; 2. Aged 18-75 years; 3. Patients who were first diagnosed with liver metastasis of rectal cancer and had not received radiotherapy or chemotherapy; 4. Recurrence risk score CRS = 40%; 6. Patients diagnosed with colorectal liver metastasis after pathological evaluation of postoperative specimens; 7. ECOG score 0-2; 8. No previous history of other malignant tumors; 9. The function of major organs was normal, and the following criteria were met during chemotherapy: blood routine: hemoglobin >= 90 g/L; Neutrophil number >= 1.5 x 10^9/L; Platelet count >= 60 x 10^9/L. Biochemical examination: albumin >= 29g/L; Alanine transaminase and aspartate transaminase < 5 x ULN; Total bilirubin <= 3.0 x ULN; Creatinine <= 1.5 x ULN; 10. The patient had good compliance and cooperated with the complete course of adjuvant therapy.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from serious cardiovascular, cerebrovascular and pulmonary diseases; 2. Neoadjuvant chemoradiotherapy or conversion therapy; 3. Patients whose liver lesions were diagnosed as primary liver cancer by postoperative specimens; 4. Patients with other organ metastases besides liver metastases; 5. Patients with postoperative pathology indicating non-R0 resection; 6. Patients with unknown infection or fever; 7. Patients undergoing allogeneic organ transplantation or bone marrow transplantation; 8. Patients infected with human immunodeficiency virus (HIV); 9. Pregnant and lactating women, and women or men who refuse to take contraceptive measures; 10. Patients with active multiple primary cancers; 11. Patients with mental illness or who are deemed unfit to participate in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Tumor recurrence rate;Liver metastasis recurrence rate;Incidence of acute and chronic side effects;Quality-of-life Score; | — |
Countries
China
Contacts
Public ContactBin Yang
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed