Monitoring of tumor volume of hepatocellular carcinoma by circulating tumor DNA

JRCT ID: jRCT1020200017

Registered date:17/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular Carcinoma
• Date of first enrollment: 15/08/2020
• Target sample size: 5
• Study type: Observational

Outcome(s)

• Primary Outcome: Objective response rate assessed by mRECIST on CT and MRI at 2 months after the start of treatment.
• Secondary Outcome: Progression free survival and overall survival as assessed by mRECIST on CT and MRI two months after the start of treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with BCLC stage B or C unresectable hepatocellular carcinoma who are not eligible for local therapy. Patients who are receiving a new molecularly targeted drug such as sorafenib or lenvatinib will be eligible for the study. Other patients participating in clinical trials of molecularly targeted drugs being conducted will also be eligible.

Exclude criteria

Any of the following 1) to 4)
1) Patients who have been informed by themselves or their representatives that they will not participate in the research.
2) Patients who are deemed unsuitable for inclusion in the study by the attending physician.
3) Patients whose mutant genes were not identified in next-generation sequencing analysis of primary tissues.
4) Patients with no next of kin to obtain final consent for pathology at the time of death.

Related Information

• Primary Sponsor: Suzuki Yuji
• Secondary Sponsor: Takikawa Yasuhiro