Colorectal Cancer
Conditions
Interventions
Placebo combined with conventional chemotherapy group:Placebo plus conventional chemotherapy
Xihuangjiedu capsule group:Xihuang Jiedu Capsules combined with conventional chemotherapy
Sponsors
Sanming Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Based on current clinical practice guidelines and previous experience in advanced clinical research in colorectal cancer we have developed strict inclusion criteria. Eligible patients 1) must be diagnosed with colorectal cancer by histopathology have measurable metastatic lesions that meet RECIST 1.1 standards and are determined as Phase III/IV according to the AJCC 8th Edition staging system. 2) The patient's age should be between 18 and 75 years old the ECOG physical strength score is 0-2 points and the expected survival period is no less than 3 months. 3) Patients need to have sufficient organ functional reserves including: absolute neutrophil count =1.5×10^9/L platelet count =100×10^9/L hemoglobin =9 g/dL total bilirubin =1.5 times the upper limit of normal (ULN) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 times the upper limit of normal (if liver metastasis exists =5 times the upper limit of normal) and creatinine clearance =50 mL/min. 4) All patients must have rece
Exclusion criteria
Exclusion criteria: Patients with the following conditions will be excluded: 1) Received traditional Chinese medicine treatment within 4 weeks of enrollment; 2) Received untreated or unstable brain metastasis; 3) Severe cardiovascular disease including myocardial infarction unstable angina pectoris New York Heart Association Grade III/IV heart failure or poorly controlled hypertension; 4) Active infections requiring systematic treatment; 5) Known allergic to the components of Xihuang Jiedu Capsules; 6) Other malignant tumors within 5 years (except for fully treated non-melanoma skin cancer or carcinoma in situ); 7) Pregnant or breastfeeding women; 8) Mental disorders that may affect study compliance; 9) Participate in other interventional clinical trials within 30 days of enrollment; 10) or undergo major surgery within 4 weeks of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessment;Objective Remission Rate (ORR);Patient quality of life assessment;Disease Control Rate (DCR);Progression-free survival PFS; | — |
Countries
chian
Contacts
Public ContactBiru Zheng
Building 13 Shazhou New Village Sanyuan District Sanming City Fujian Province
Outcome results
None listed