Phase IIa Clinical Trial for Dose-Finding, Pharmacokinetics, Safety, Immunomodulatory Activity, and Inhibitory Activity on Cancer Progression of Capsule Formulation of the Standardized Extarct of Atractylodes lancea in Patients with Unresectable or Metastatic Liver Tumor
Phase 2
- Conditions
- late-stage cholangiocarcinomacholangiocarcinoma,Atractylodes lanceastandardized extractphase IIa clinical trial
- Registration Number
- TCTR20210129007
- Lead Sponsor
- ational Research Council of Thailand (NRCT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetic parameters Day 0 (at 0, 0.5, 1, 1.5, 2, 2.5, 3,4,5 and 6 hours); day 15 (at 0,0.5,1,1.5,2.5,3,4,5,6 hours); day 29 (at 0,0.5,1,1.5,2,2.5,3,4.5 and 6 hours) pharmacokinetic analysis
- Secondary Outcome Measures
Name Time Method adverse events weekly for 4 months clinical signs and symptoms and laboratory tests