Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma/Metastatic Liver Tumors

A Phase I Clinical Study of Dose Escalation in Stereotactic Body Radiotherapy for Hepatocellular Carcinoma/Metastatic Liver Tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030220731

Enrollment

Registered

2023-03-25

Start date

2023-03-25

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, liver neoplasms hepatocellular carcinoma, liver neoplasms

Interventions

Stereotactic body radiotherapy for hepatocellular carcinoma or liver metastatic tumors. The total dose is 50 / 60 / 70 Gy in 10 fractions once a day. We start with the lowest dose level and gradually

D016634

Stereotactic body radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Patients with pathologically or clinically (by dynamic contrast-enhanced CT or EOB-MRI of the liver) diagnosed primary or recurrent hepatocellular carcinoma or localized metastatic liver tumor who are not candidates for radical treatment (liver resection, RFA, liver transplantation) and will receive stereotactic body radiation therapy. b) Patients whose pre-enrollment treatment plan meets the dose constraints". c) Patients with Child-pugh classification grade A or B. d) Performance status (PS) of 0-2. e) Over 18 years old. f) Patients who have given their written consent to participate in the study.

Exclusion criteria

Exclusion criteria: a) Patients who do not consent to participate in the study. b) With lymph node metastasis or distant metastasis in other organs. c) With a history of prior radiotherapy to liver. d) With WBC <2,000/mm3, HB <8g/dl, or Plt <50.000/mm3. e) Patients participating in other clinical trials that may affect the conduct or outcome of this study. f) Other patients who are deemed inappropriate to participate in this study by the investigator or co-investigaters.

Design outcomes

Primary

Measure	Time frame
Incidence rate of Grade 3 oredr higher adverse events that occurred within 90 days after the end of radiation therapy (evaluated by Common terminology Criteria for Adverse Events: CTCAE version 5.0)	—

Secondary

Measure	Time frame
1.Incidence of any adverse events within 90 days of completion of radiotherapy (as assessed by CTCAE version 5.0 JCOG) 2.Incidence of adverse events occurring after 91 days of radiotherapy (as assessed by CTCAE version 5.0 JCOG) 3.Incidence rate of adverse events based on subjective evaluation (Patient-Reported Outcome Common Terminology Criteria for Adverse Events: PRO-CTCAE version 1.0 JCOG version) 4.Overall Survival 5.Local recurrence-free survival: Date of recurrence is the date on which dynamic CT or EOB-MRI of the liver again confirms an increase in the treated lesion or a contrast-enhancing lesion in the irradiated field.	—

Measure

Time frame

1.Incidence of any adverse events within 90 days of completion of radiotherapy (as assessed by CTCAE version 5.0 JCOG) 2.Incidence of adverse events occurring after 91 days of radiotherapy (as assessed by CTCAE version 5.0 JCOG) 3.Incidence rate of adverse events based on subjective evaluation (Patient-Reported Outcome Common Terminology Criteria for Adverse Events: PRO-CTCAE version 1.0 JCOG version) 4.Overall Survival 5.Local recurrence-free survival: Date of recurrence is the date on which dynamic CT or EOB-MRI of the liver again confirms an increase in the treated lesion or a contrast-enhancing lesion in the irradiated field.

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Contacts

Public ContactKosuke Morishima

The University of Tokyo Hospital

morishimak-rad@h.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

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