Carbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis(GUNMA1801)

Carbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis(GUNMA1801) - CCarbon-ion radiation therapy combined with hepatic arterial infusion chemotherapy for locally advanced hepatocellular carcinoma with tumor thrombosis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032991

Enrollment

Registered

2018-06-30

Start date

2018-06-30

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

Carbon ion raidiotherapy 60Gy(RBE)/12fr./3 weeks Hepatic arterial infusion chemotherapy (HAIC) day 1: cisplatin 20mg/body + 5FU 250mg/body day 2-5: cisplatin 10mg/body + 5FU 250mg/body A total

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or clinically diagnosed hepatocellular carcinoma. 2) Unfit for resection or liver transplantation 3) Unfit for percutaneous tumor ablation 4) Patients untreated by previous systemic chemotherapy or cisplatin-based transarterial therapy. 5) Patients without previous treatment within four weeks 6) Patients with major portal vein and/or hepatic vein invasion. 7) Patients without extrahepatic metasitasis 8) The maximum tumor is measurable and tumor size is less than 12 cm 9) Patients without direct tumor invasion to adjacent organs 10) ECOG PS: 0-1 11) Child-Pugh score of the patient is from 5 points to 9 points. 12) Absence of uncontrolled ascites and/or pleural effusion. 13) Clinical laboratory data is fulfilled with the criteria 14) 20-year-old or older. 15) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.

Exclusion criteria

Exclusion criteria: 1) Unfit for hepatic arterial reservoir implantation 2) Active or severe gastro-esophageal varix or bleeding 3) Patients on anti-platelet or anti-coagulation therapy 4) A history of severe allergic reaction to contrast medium or local anesthesia. 5) A history of radiation hypersensitivity 6) Patients with severe co-morbidity

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Adverse event, Tumor response (response rate, disease control rate), Time-to-local progression,Progression-free survival	—

Countries

Japan

Contacts

Public ContactKei Shibuya

Gunma University Heavy-ion Medical Center

shibukei@gunma-u.ac.jp027-220-8378

Outcome results

None listed

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