colorectal cancer liver metastases
Conditions
Interventions
experimental group:detoxification and dispersal herbs combined with TACE
control group:placebo (herb) combined with TACE
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years; 2. Karnofsky score (> 70); 3. Histological or cytological diagnosis of liver metastasis from colorectal cancer; 4. Unresectable colorectal liver metastases that cannot be resected or refused to be operated on and that are resistant to chemotherapy or refractory to extensive liver metastases without obvious extrahepatic metastases; 5. There must be measurable lesions that meet the RECIST criteria; 6. The organ function tests of the patients were in accordance with the following laboratory indicators (white blood cells (> 3.5x10^9/L), neutrophils (> 2.0) X 10^9/L, hemoglobin (> 8 g/L), platelet (> 100 x 10^9/L), serum creatinine < 2.0 mg/dL (177 um, ol/l), total bilirubin (< 1.5 times the upper limit of normal value), alanine aminotransferase (< 2.5 times the normal value), glutamic oxaloacetic aminotransferase (< 2.5 times the normal value). 7. Patients with jaundice must undergo biliary drainage and decompression before admission. 8. Understanding and signing written informed consent; 9. Life expectancy is more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients with TACE treatment contraindication; 2. Child-Push C grade of liver function; 3. Irreparable coagulation dysfunction and severe abnormal hemogram; 4. Plenty of ascites; 5. Central nervous system damage or pia mater disease; 6. Those with infection and need intravenous antibiotic therapy; 7. Other serious diseases or conditions, including congestive heart failure (New York Heart Association Class III or IV), active HIV infection or HIV disease, active gastrointestinal bleeding, mental disorders, etc. - Subjects had a history of other primary cancers, except for the following: A) Non-melanoma skin cancer cured by excision; B) Cured in situ cervical cancer; 8. Pregnant or lactating women. 9. People taking other Chinese medicines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Quality of life;Quality of life; | — |
Countries
China
Contacts
Public ContactZhu Xiaoyan
Fudan University Shanghai Cancer Center
Outcome results
None listed