colorectal cancer
Conditions
Interventions
Experimental group:Buzhong Tiaogan Granules+chemotherapy (CAPEOX/mFOLFOX6/FOLFIRI+Bevacizumab/Cetuximab)
Control group:chemotherapy (CAPEOX/mFOLFOX6/FOLFIRI+Bevacizumab/Cetuximab)
Sponsors
Shanxi Province Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-80 years old (including critical value), men and women are not limited, and those who are expected to survive =3 months; 2) Meet the above-mentioned western medicine diagnosis standards, have a definite pathological diagnosis of colorectal adenocarcinoma, and has been evaluated by multiple disciplines as unresectable with only liver metastasis or liver dominated metastasis. 3) There are evaluated liver metastases (maximum diameter =10mm), and cannot be treated by surgical resection or local ablation at the beginning of the test. 4) Expressive extractive liver disease (EHD): internal metastases; a single part of other extracurricular diseases except lung metastases is also allowed (for example, multiple lymph nodes in a lymph node area). The above evaluation is based on multidisciplinary consultatio 5)Have not received advanced systemic treatment or local treatment for liver metastases in the past; 6) Meet the above -mentioned Chinese medicine diagnostic standards, Chinese medicine syndrome differentiation is spleen deficiency liver stagnation, stasis and drug interoperability certificate; 7) KPS score = 60 points; 8) The function of other important organs is basically normal, without other primary tumors and severe diseases such as heart, liver and kidney, are defined as follows: Blood routine examination: white blood cell count (WBC) =3.0*109/L; Neutral granulocyte counting (ANC) =1.5*109/L; platelet count (PLT) =100*109/L; hemoglobin (HB) =90g/L; biochemical examination: albumin =30g/L; creatinine = 1.5 times the upper limit of normal value (ULN) or creatinine clearance =50ml/min; Total bilirubin (BLT) = 1.5 times the upper limit of normal value (ULN); ALT and AST levels = 5 * ULN; International standardized ratio (INR) =1.5, coagulinase original time (PT) and activated part of the coagulation activation time (APTT) = 1.5 times ULN; urine protein <2+; if urine protein =2+, 24 -hour urine protein display protein must be =1g; 9) Clear consciousness, oral or written to communicate with obstacles; 10) Inpatients who are willing to cooperate with the follow -up and have a comprehensive medical record information; 11) The subjects voluntarily participate in and sign the consent of informed consent.
Exclusion criteria
Exclusion criteria: 1)Non-primary colorectal cancer with an unclear diagnosis; 2) Patients with polygenic carcinoma combined with other malignancies; 3) Patients with extensive peritoneal metastases or MSI-H/dMMR or other targeted therapies; 4) Patients with intestinal obstruction or intestinal perforation or intestinal bleeding, which is defined as follows: stool occult blood 3+ or more or visible bleeding. 5) Patients with jaundice; 6)Those who cannot or are unwilling to receive Chinese medicine treatment; 7) Those who have allergic diseases or are allergic or have an allergic to any drugs or their components in this experiment; 8) Pregnant women; 9) Patients with severe hepatic and renal insufficiency; 10) Those who cannot complete follow-up as required; 11) Participants who had participated in any other clinical trial within 1 month prior to enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;Quality of life score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Liver specific progression-free survival;Disease control rate;Evaluation of TCM Syndrome Efficacy;Piper fatigue score;KPS score;Safety evaluation; | — |
Countries
China
Contacts
Public ContactHao Shulan
Shanxi Province Hospital of Traditional Chinese Medicine
Outcome results
None listed