Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients

Synergistic Anti-tumor Effect of ChangTai Keli Based on Chemotherapy for Colon Cancer Patients：a Randomized, Parallel-group, Double-blind, Multicenter Clinical Study

The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind, multicenter clinical study.

Although many therapies exist and are being developed to relieve symptoms for colon cancer, there are few randomized controlled clinical trials to evaluate comprehensive Traditional Chinese medicine (TCM) interventions in colon cancer. The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients. This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the synergistic anti-tumor effect of TCM on colon cancer patients. Following a run-in period, approximately 360 subjects will be randomly assigned to conventional chemotherapy treatment group, ChangTai Keli and conventional chemotherapy treatment group for 26 weeks. After the 26 weeks treatment period, subjects in two treatments arms will follow-up 36 months.

Inclusion Criteria:

1. collaboration from hospital oncology patients in hospital. Confirmed by pathology or cytology for colon cancer, Ⅱ A - Ⅳ period of patients with colon cancer line (or late postoperative palliative chemotherapy).
2. age > 18 years of age, and the 75 - year - old patient or less;
3. fitness score (ECOG PS) 2 minutes or less, expected lifetime > 6 months;
4. volunteered for the clinical research, and sign the informed consent.

Exclusion Criteria:

1. patients with other primary malignant tumors within 1 year;
2. intentional, severe liver and kidney disease patients with serious obstacle and function;
3. pregnancy or lactation women, mental disorders to cooperate to complete the healer;
4. is in other subjects or attended other drugs test interval < 3 months.
5. do not meet the inclusion criteria;