Refractory advanced colorectal cancer in the treatment with integrated traditional Chinese and western medicine: a multi-center clinical study

Not Applicable

Conditions: colorectal cancer

Registration Number: ITMCTR2200006741

Lead Sponsor: onghua Hospital, Shanghai University of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Stage IV disease and histologically confirmed adenocarcinoma of the colon or rectum;
2.Measurable index lesion according to RECIST1.1 criteria;
3.Age =18 years old;
4.RAS mutation (including KRAS, NRAS and HRAS)
5.Organ function must meet the following requirements: (a) Blood routine: white blood cell count =3×109/L, neutrophil count =1.5×109/L, hemoglobin =90g/L, platelet count = 75× 109/L. (b) Liver function: total bilirubin =1.5×ULN, ALT and AST=2.5×ULN (liver metastasis =5×ULN). (c) Renal function: creatinine =1.5×ULN, creatinine clearance rate > 50 mL/min. (d) Coagulation function: prothrombin time =1.5×ULN, activated partial thromboplastin time =1.5×ULN, international standardized ratio =1.5×ULN. (e) Electrolyte: serum magnesium and serum potassium =LLN, allowing electrolyte correction during screening;
6.Patients who intend to receive first-line treatment or withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy;
7.Patients who are assessed as spleen deficiency syndrome;
8.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9.Estimated life expectancy >3 months;
10. Patients have informed consent and can cooperate with long-term follow-up.

Exclusion Criteria

1.Other histological types of colorectal cancer except adenocarcinoma;
2.RAS wild type status (including KRAS, HRAS and NRAS);
3.Intestinal obstruction (except for patients who were relieved by fistulation or implantation stent) and active inflammatory bowel disease (patients who need medical intervention or have symptoms currently) before the study;
4.Pregnant or breast feeding women; man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study;
5.Patients with mental disorders who cannot cooperate with treatment and follow-up;
6.Clinically significant cardiovascular diseases, such as cerebrovascular accident, myocardial infarction and unstable angina pectoris, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication (within 6 months before the study);
7.Uncontrollable hypertension;
8.High-dose aspirin (> 325mg/d) in a long term;
9.Bleeding tendency or severe coagulation dysfunction;
10.Inability to take drugs orally, lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome and other diseases that the doctor thinks may interfere with gastrointestinal movement or absorption;
11.Severe proteinuria (nephrotic syndrome);
12.History of active tuberculosis (Bacillus tuberculosis [TB]) infection or active or chronic infection requiring systemic treatment;
13.Serious and unhealed wounds, ulcers or fractures;
14.Known history of brain metastasis, spinal cord compression or primary brain tumor;
15.History of central nervous system diseases (such as epilepsy or stroke) and the standard medication can't control the disease well;
16.Patients who have undergone major surgery, open biopsy or experienced serious trauma within 28 days before the study;
17.Other malignant tumor diseases were diagnosed within 5 years before the start of the study (except basal and squamous cell carcinoma or cervical cancer in situ which has been fully treated);
18.Those who are participating in other clinical trials;
19.Other situations that the researcher thinks are not suitable for inclusion.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression free survival;

Secondary Outcome Measures

Name	Time	Method
duration of disease control;incidence of treatment-related adverse events;score of spleen deficiency;chemotherapy completion rate;quality of life of patients with colorectal cancer;overall survival;