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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Colon Cancer

Clinical Trial Details

NCT number	NCT02510118
Study type	Interventional
Source	Nanjing NingQi Medicine Science and Technology Co., Ltd.
Contact	Yin Qingfeng, manager
Phone	0086-025-85632992
Email	y_qingfeng@163.com
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	June 2015
Completion date	June 2018

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