colorectal cancer
Conditions
Interventions
Experimental group:Ganoderma lucidum spore powder
Control group:Placebo
Sponsors
Tianjin Nankai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion in the first phase of trial patients included criteria: 1. Patients with colorectal cancer who have a definite diagnosis, and the TNM staging meets one of the following conditions: (1) There are high risk factors in stage II (requires postoperative chemotherapy); (2) Phase III; (3) Patients who underwent complete surgery (R0) resection after stage IV chemotherapy reduction, no distant metastasis outside the liver. The surgical methods include open surgery and endoscopic surgery. 2. the primary tumor and metastases can be completely removed by surgery, or surgical removal of most metastases, residual radiofrequency ablation. 3. Can receive and only receive adjuvant chemotherapy with postoperative CapeOx (XELOX) regimen, and plan to use a chemotherapy regimen of more than 3 months (excluding 3 months). 4. aged 18-80 years old, the expected survival period is more than 6 months; 5. The counts of white blood cells, neutrophils, hemoglobin and platelets before enrollment were not lower than the lower limit of normal value, the transaminase level was =60; 6, no serious heart, liver and kidney dysfunction, expected physical condition can at least tolerate 4 cycles (including 4 cycles) of the above chemotherapy; 7, can adhere to medication according to the doctor's advice and acceptance, follow-up, good compliance, can understand the situation of this study, and signed informed consent. Additional criteria for inclusion in patients undergoing Phase II trials: The first phase of the trial has been completed, and those who underwent complete surgery (R0) resection after stage III and IV chemotherapy reduction. And the metastatic lesions are no more than 3, the largest ones are <=5cm in diameter, and there is no distant metastasis outside the liver.
Exclusion criteria
Exclusion criteria: 1. Previous or combined with other malignant tumor history, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. Those who have been determined to use the 3-month Cape Ox (XELOX) regimen (even if they can tolerate and do not use the 6-month regimen); 3. Patients with secondary surgery after recurrence; 4. Patients who need postoperative concurrent radiotherapy, those who need preoperative radiotherapy and chemotherapy in stage II/III patients, and those who have less than 3 months of chemotherapy (excluding 3 months); 5. stage IV patients: a. need to undergo a second operation to remove the primary and metastatic lesions, b. can not achieve complete resection or intraoperative discovery of new metastases, c. simply use radiofrequency ablation ablation Treatment of metastases; 6. severe liver and kidney function; 7. patients have intestinal obstruction can not take oral drugs, need intravenous high-energy nutrition; suffering from malabsorption syndrome or other diseases affecting the absorption of the gastrointestinal tract, or active peptic ulcer disease; 8. Any situation that is unstable or may compromise patient safety and compliance with the study; 9. The investigator judged that the estimated survival time was less than 6 months based on clinical treatment experience and patient status; 10. The investigator judges subjects who are poorly compliant or unable to cooperate with the study; 11. Participate in other clinical trials that may affect the outcome of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chemotherapy tolerance improvement; | — |
Countries
China
Contacts
Public ContactShu Yan
Tianjin Nankai Hospital
Outcome results
None listed