colon cancer
Conditions
Interventions
experimental group:Qushi Jiedu Formula
control group:Placebo for Qushi Jiedu Formula
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients with colorectal cancer diagnosed by tissue or cytopathology. (2) Patients who have undergone radical surgery with postoperative pathological staging of III and high-risk stage II (based on the NCCN clinical practice guidelines in colorectal cancer [version 1. 2022]). (3) Completed adjuvant chemotherapy with 4-6 cycles of Xelox, 6-12 cycles of FOLFOX or Fluorouracil monotherapy, and no further adjuvant chemotherapy in the near future. (4) Last chemotherapy = 3 months before enrolment. (5) Eastern Cooperative Oncology Group(ECOG) score = 2 points. (6) Age 18 to 75 years. (7) Normal hepatic and renal function. Normal renal function: serum creatinine = 1.5 mg/dl (133 µmol/L) or creatinine clearance = 60 ml/min; normal liver function: serum total bilirubin = 1.5 times the upper limit of normal (ULN), serum glutamic oxalacetic transaminase (AST) & glutamic alanine transaminase (ALT) = 2.5 times ULN. (8) Signed informed consent, patient willingness to accept this regimen, ability to adhere to the medication, and good compliance.
Exclusion criteria
Exclusion criteria: (1) Inability to complete the baseline assessment form. (2) Bowel obstruction or incomplete bowel obstruction. (3) Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, bleeding tendency. (4) Pregnant or lactating women. (5) Patients with comorbid depression, mania, obsessive-compulsive disorder and schizophrenia. (6) Patients with a history of autoimmune disease, hematological disease, organ transplantation, long-term use of hormones or immunosuppressive agents. (7) Combination of other uncontrolled tumors. (8) Patients who have received or are scheduled to receive preoperative neoadjuvant radiotherapy. (9) Patients with severe brain or psychiatric disorders that affect the patient's ability to self-report. (10) History of organ transplantation (including bone marrow autotransplantation and peripheral stem cell transplantation). (11) Persons lacking legal capacity or for medical or ethical reasons that affect the continuation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence and metastasis rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Circulating tumor cell count;Dampness syndrome scale; | — |
Countries
China
Contacts
Public ContactHaibo Zhang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed