Colorectal Cancer
Conditions
Interventions
experimental group??:Herb-based therapy combined with conventional Western medical treatment.
??treatment group??:Placebo combined with conventional Western medical treatment
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Pathological diagnosis of colorectal cancer meeting potentially resectable criteria; (2) Clinical stage T4b or IVa (AJCC 8th edition TNM staging), assessed as potentially resectable; (3) Immunohistochemistry or genetic test results showing pMMR or MSS/MSI-L; (4) ECOG PS score =2; (5) Any gender, age 18 to 75 years; (6) Laboratory data indicating acceptable chemotherapy tolerance, without severe cardiac/hepatic/renal dysfunction, meeting: - Hematology: WBC =3.5x10^9/L; ANC =1.5x10^9/L; PLT =100x10^9/L; Hb =90 g/L; - Liver/kidney function: TBIL =1.5xULN; AST/ALT =2.5xULN; Cr =1.5xULN; (7) Voluntarily signed informed consent, good medication adherence and compliance.
Exclusion criteria
Exclusion criteria: 1. Inability to complete baseline evaluation; 2. Intestinal obstruction or incomplete intestinal obstruction where oral medication is not possible; 3. Any unstable or potentially life-threatening condition that may compromise patient safety and adherence to the study, including pregnancy, planned pregnancy, breastfeeding, and mental disorders (e.g., schizophrenia, depression, and obsessive-compulsive disorder); 4. allergy to components of the Quxie formula; 5. Patients requiring radiotherapy during the treatment period; 6. History of other malignant tumors, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ; 7. Receipt of investigational drugs or participation in other clinical trials within 4 weeks prior to the administration of study intervention; 8. Previous treatment toxicities and/or complications have not recovered to CTCAE = Grade 1, except for alopecia and = Grade 2 peripheral neuropathy; 9. Concurrent gastrointestinal bleeding, perforation, or other emergencies; 10. Investigators judge the patient unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ??R0 resection rate?;Disease Free Survival,DFS;Objective Response Rate;Major Pathological Response;Time to Progression;Overall Survival Rate,OSR;??Quality of life (QOL) and symptom burden during treatment?;Adverse reactions during chemotherapy?;??Tumor markers and imaging examinations?;Changes in traditional Chinese medicine (TCM) syndromes?; | — |
Countries
China
Contacts
Public ContactYun Xu
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed