At a glance
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A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating KD018, Irinotecan, and 1 other intervention for Colorectal Neoplasms. Completed, enrolled 33 participants across 2 sites.
Detailed Summary
The proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our rationale for the therapeutic use of KD018 is its potential activity in reducing chemotherapy-induced toxicity, especially diarrhea.
Study Details
Timeline
Interventions
Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.