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Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism

Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism - Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000052641
Enrollment
100
Registered
2023-12-07
Start date
2023-12-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Chronic Hepatitis, Hepatocellular Carcinoma, Liver cirrhosis

Interventions

None listed

Sponsors

Nagoya University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients aged 18 and over undergoing treatment for liver diseases including HCC at our institution Patients with an ECOG Performance Status (PS) of 0-2 Consent obtained from the patient in writing

Exclusion criteria

Exclusion criteria: Patients with galactosemia Patients who have experienced allergies to foods containing sugar alcohols Patients with poorly controlled diabetes Patients who wish to be excluded from the study Patients who are pregnant, nursing, possibly pregnant or wish to become pregnant, or wishing to raise children Other patients whom the physician has judged to be inappropriate for safely conducting this trial

Design outcomes

Primary

MeasureTime frame
In patients with hepatocellular carcinoma undergoing chemotherapy, identifying differences in gut microbiota and intestinal permeability between the groups with favorable treatment outcomes (where the response during administration is evaluated as stable disease (SD) or better, according to m-RECIST and RECIST criteria) and the groups with unfavorable outcomes (where the response during administration is evaluated as progressive disease (PD)).

Secondary

MeasureTime frame
Identification of gut microbiota and differences in intestinal permeability associated with adverse events during the treatment period.

Countries

Japan

Contacts

Public ContactKenta Yamamoto

Nagoya University Hospital Department of Gastroenterology and Hepatology

kenta-y@med.nagoya-u.ac.jp052-744-2169

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026