Efficacy of butyric acid preparations in patients with hepatocellular carcinoma undergoing chemotherapy

JRCT ID: jRCTs061230077

Registered date:15/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable hepatocellular carcinoma
• Date of first enrollment: 15/11/2023
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Patients with unresectable hepatocellular carcinoma will receive MiyaBM granule orally at a dose of 1.5g or MiyaBM 3 tablets per day. This will be administered until progress of tumor(assume average of 12 months).

Outcome(s)

• Primary Outcome: progression free survival

Secondary Outcome

1 Response rate
2 Disease cotrol rate
3 Overall survival
4 Change of intestinal flora
5 Adverse Events and side effects

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 18 age old over
2 Regardless of gender
3 Patients diagnosed with unresectable hepatocellular carcinoma
4 Patients who will receive treatment with Durvalumab and Tremelimumab
5 Patients who have been fully informed consent

Exclude criteria

1 Patients with Child-Pugh score over 8
2 Patients used to have hypersensitivity with butyric acid
3 Being pregnant or possibly pregnant
4 Patients who judged as inappropriate candidate by the chief medical examine

Related Information

• Primary Sponsor: Otsuka Motoyuki