Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy

Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy - Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020862

Enrollment

Registered

2016-02-03

Start date

2016-04-01

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

Intrahepatic cholangiocarcinoma

Interventions

Proton Beam Therapy 22 times, once a day, 5 times a week, maximam 46 days, 30 cases

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Pathologically proven cholangiocarcinoma (adeno/adenosquamous carcinoma) 2)Inoperable 3)Nonresponsive to chemotherapy 4)Tumor diameter less than 12cm 5)Inclusive in the irradiation field 6)Child-pugh class A/B 7)PS 0-2 8)Both inpatients and outpatients 9)Laboratory data within 14 days before registration as follows: -White blood cells>=2,000/mm3 - Platelet >=5*104/mm3 -Hemoglobine>=8,0 g/dL -Total bilirubin<2,0 mg/dL -Serum Albumin>3,5 g/dL -Serum creatinine<=1,5 mg/dL -Prothrombin time(%)>70% 10)Blood transfusion not received within 14 days before registration 11)Age>=20, <80 12)Informed consent obtained

Exclusion criteria

Exclusion criteria: 1)Postoperative recurrence 2)Presence of lymph nodes metastases 3)Presence of distant metastases 4)Presence of active double cancers 5)Infection required systematic therapy 6)Body temperature more than 38 degree Celsius at screening 7)Pregnacy,demand of pregnant,28 days within childbirth and lactating 8)Psychosis or complicated mental symptom which causes difficult to entry 9)Steroid or other immunosuppressive drugs usage 10)Uncontrolled diabetes 11)Uncontrolled hypertension 12)Unstable angina within 3 weeks of myocardial infarction within 6 months 13)Presence of interstitial pneumonitis, pulmonary fibrosis, or severe emphysema which is diagnosed by chest CT 14)Esophageal varix (hemorrhagic,history of hemorrhage, more than F2,RC2) 15)Inappropriate decision by a principal investigator 16)Entry to other clinical research

Design outcomes

Primary

Measure	Time frame
2-year overall survival rate	—

Secondary

Measure	Time frame
1)2-year progression free survival rate 2)2-year local progression free survival rate 3)Adverse effect frequency 4)Radiation induced liver disease	—

Countries

Japan

Contacts

Public ContactToshiyuki Okumura

University of Tsukuba Hospital Department of Radiation Oncology

okumura@pmrc.tsukuba.ac.jp029-853-7100

Outcome results

None listed

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