The efficacy and safety of autologous gamma/delta T cell transfer therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer

The efficacy and safety of autologous gamma/delta T cell transfer therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer - Autologous gamma/delta T cell therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001417

Enrollment

Registered

2008-10-08

Start date

2008-09-01

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 biliary tract cancer

Interventions

Gamma/delta T cells are injected on day0, day14, day28, day42, day56, day70, day84, day98. Gemcitabine on day-3, day4, day11, day25, day32, day39, day53, day60, day67, day81, day88, day95.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Intrahepatic cholangiocarcinoma or biliary tract cancer patients who received surgical resection: - Pathological diagnosis of intrahepatic cholangiocarcinoma or biliary tract cancer; - High risk of recurrence (positive lymph node, positive margin or multiple intrahepatic cancer); - Life-expectancy is more than 3 months; - Performance status is 0-1; - No serious abnormality in heart, lung, bone marrow, liver, and renal functions.

Exclusion criteria

Exclusion criteria: Patients who have: - Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them; - Active enteritis; - Active autoimmune diseases; - Active infections; - Other cancers; - Other serious complications; - Continuous systemic administration of steroids.

Design outcomes

Primary

Measure	Time frame
Relapse free survival Recurrence rate (1 and 2 years)	—

Secondary

Measure	Time frame
Overall survival Response rate Survival rate (3 and 5 years) Response of tumor-related markers Immunological responses Safety	—

Countries

Japan

Contacts

Public ContactKazuhiro Kakimi

Graduate School of Medicine, The University of Tokyo Department of Immunotherapeutics

immunotherapy-admin@umin.ac.jp03-5805-3161

Outcome results

None listed

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