Monitoring of tumor volume of hepatocellular carcinoma by circulating tumor DNA

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; advanced-stage hepatocellular carcinoma, unresectable hepatocellular carcinoma; D006528

• Registration Number: JPRN-jRCT1020200017
• Lead Sponsor: Suzuki Yuji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate assessed by mRECIST on CT and MRI at 2 months after the start of treatment.

Secondary Outcome Measures

Name	Time	Method
Progression free survival and overall survival as assessed by mRECIST on CT and MRI two months after the start of treatment.