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Prospective observational study of systemic therapy for unresectable HCC in Japan: Real World data of systemic therapy for HCC

Prospective observational study of systemic therapy for unresectable HCC in Japan: Real World data of systemic therapy for HCC - PRISM Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040488
Enrollment
2000
Registered
2020-06-01
Start date
2020-07-01
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

Hepatocellular carcinoma

Interventions

None listed

Sponsors

Investigator Initiated Study Promotion Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients who histologically or clinically diagnosed with HCC. 2 Patients who scheduled for systemic therapy for HCC. At the start of systemic therapy, other treatments (TACE, etc.) will not be used in combination. 3 20 years old or over. 4 Patients who obtained written informed consent of this clinical study.

Exclusion criteria

Exclusion criteria: 1 Patients with a past history of systemic therapy (including molecular targeted therapies, immune checkpoint inhibitors, investigational drugs). Patients with prior history of hepatectomy, local ablative therapy, TACE, and radiation therapy are not excluded. 2 Patients participating in clinical trials requiring some intervention, such as new agents. 3 Patients who are judged to be unsuitable to enroll in the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Overall survival of each treatment regimen at each treatment line

Secondary

MeasureTime frame
Progression free survival, overall response rate, disease control rate and time to treatment failure of each regimen at each treatment line Grade 3 or greater adverse events of each regimen at each treatment line Drug exposure (initial dose, duration of treatment and dose intensity, transition rate to next treatment) of each regimen at each treatment line

Countries

Japan

Contacts

Public ContactShinji Itoh

Kyushu University Department of surgery and science, Graduate school of medical science

itoshin@surg2.med.kyushu-u.ac.jp092-642-5466

Outcome results

None listed

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