PhaseI/II study of WT1 peptide vaccination plus gemcitabine and cisplatin versus gemcitabine and cisplatin in advanced biliary tract cancer

PhaseI/II study of WT1 peptide vaccination plus gemcitabine and cisplatin versus gemcitabine and cisplatin in advanced biliary tract cancer - WT-BT trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004886

Enrollment

106

Registered

2011-01-18

Start date

2011-01-01

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

advanced biliary tract cancer

Interventions

Gemcitabine+cisplatin+WT1 peptide vaccination gemcitabine : 1,000mg/m2, day1, 8, q21 cisplatin : 25mg/m2, day1, 8, q21 WT1 vaccination : 0.4ml x2, ay1, 8, q21 Gemcitabine+cisplatin gemcitabin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer 2) Recurrent or unresectable biliary tract cancer 3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma 4) Without CNS metastasis 5) Without moderate or more ascites/pleural effusion 6) No previous therapy against biliary tract cancer 7) No previous operation, chemotherapy or radiotherapy and no reccurence against any other malignancies within 5 years 8) No previous chemotherapy of gemcitabine or cisplatin against any other malignancies 9) ECOG PS of 0 or 1 10) Sufficient oral intake 11) Aged 20 to 80 years old 12) Adequate organ functions 13) HLA of A2402, A0201 or A0206 14) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia or fibroid lung 6) Active bacterial or fungous infection 7) Severe complication 8) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy 9) Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
1-year survival	—

Secondary

Measure	Time frame
progression-free survival, response rate, overall survival, 2-year survival, adverse events, severe adverse events, vaccination biomarker	—

Countries

Japan

Contacts

Public ContactMakoto Ueno

Kanagawa Cancer Center Division of Hepatobiliary and Pancreatic Medical Oncology

kantansui@kcch.jp045-391-5761

Outcome results

None listed

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