Colorectal Cancer (CRC)
Conditions
Interventions
Experimental group:Tiao Pi An Chang Fang+XELOX(CapeOX)/mFOLFOX6
Control group:Placebo+XELOX(CapeOX)/mFOLFOX6
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Eligible patients had undergone complete resection of histologically proven stage II or stage III CRC; 2. Chemotherapy with XELOX (CapeOX)/mFOLFOX6 regimen was proposed and no other treatment plans such as radiotherapy were available during the study period; 3. Syndrome differentiation is syndrome of deficiency of spleen and kidney; 4. Patients aged 18 years and 75 years. Performance status (PS) 0 or 1 on Eastern Cooperative Oncology Group (ECOG) criteria; 5. Basically normal organ function; 6. Agree to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Merge with other malignant tumors. 2. Patients who cannot be treated with Chinese herbal compound due to allergies and other reasons. 3. Patients who were combined with other antitumor drugs during the trial. 4. Significant neurological and psychiatric history. 5. Have uncontrolled serious medical disease or acute infection. 6. Patients in other clinical trials currently or within 4 weeks. 7. Pregnant and lactating patients and patients with pregnancy planning. 8. Patients with clear digestive and absorption dysfunction, or with active gastrointestinal bleeding, intestinal obstruction, intestinal perforation or for any reason cannot receive oral drug therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chemotherapy complete rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of TCM symptom scores;Incidence of adverse reactions of chemotherapy;Assessment of improvement in quality of life;Tumor markers;Immune function; | — |
Countries
China
Contacts
Public ContactCheng Zhiqiang
China-Japan Friendship Hospital
Outcome results
None listed