Neoadjuvant chemoradiation combined with gemcitabine and cisplatin for biliary tract cancer

Neoadjuvant chemoradiation combined with gemcitabine and cisplatin for biliary tract cancer - Neoadjuvant chemoradiation therapy for biliary tract cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020964

Enrollment

Registered

2016-02-11

Start date

2016-02-04

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

resectable biliary tract cancer

Interventions

Neoadjuvant chemoradiation therapy combined with gemcitabine and cisplatin gemcitabine 1000mg/m2 - 600mg/m2 cisplatin 25mg/m2 - 20mg/m2 day 1, 8 every 3 weeks, 3 course radiation 50-60 Gy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Resectable biliary tract cancer (including intrahepatic cholangiocarcinoma) Major organ function (bone marrow, heart, liver, lung, kidney, etc) are maintained. Written informed consent

Exclusion criteria

Exclusion criteria: R2 resection Estimated remnant liver volume would be less than 35% Active double cancer

Design outcomes

Primary

Measure	Time frame
Safety, Recommended dose (RD), Effect of neoadjuvant chemoradiation. Safety and RD will be evaluated using CTCAE and determined by DLT. Effect will be radiologically and pathologically evaluated.	—

Secondary

Measure	Time frame
Resection rate, R0 resection rate, Recurrent free survival, Overall survival	—

Countries

Japan

Contacts

Public ContactShogo Kobayashi

Osaka Medical Center for Cancer and Cardiovasuclar diseasese Surgery

s-kobayashi@umin.ac.jp+81-6-6972-1181

Outcome results

None listed

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