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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 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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210129007
Enrollment
90
Registered
2021-01-29
Start date
2021-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

late-stage cholangiocarcinoma cholangiocarcinoma, Atractylodes lancea standardized extract phase IIa clinical trial

Interventions

1 capsule formulation consists of 601 mg A. lancea standardized extract of A. lacea,1 capsule formulation consists of 601 mg A. lancea standardized extract of A. lacea,standard supportive care for c
A. lancea at 1,000 mg per day for 90 days together with standard supportive care,A. lancea at 1,000 mg per day for 14 days, followed by 1,500 mg for 14 days, followed by 2,000 mg for 62 days together

Sponsors

National Research Council of Thailand (NRCT)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
adverse events weekly for 4 months clinical signs and symptoms and laboratory tests

Countries

Thailand

Contacts

Public ContactKesara NaBangchang

Thammasat University

kesaratmu@yahoo.com0818111678

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026