Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency

Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency - Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006047

Enrollment

Registered

2011-09-01

Start date

2012-04-01

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

cholangiocarcinoma

Interventions

Biweekly administration of Panitumumab (6mg/kg, div, over 1hr), evaluation of adverse effect grade with NCI-CTC ver.4 and its frequency. administration is continued untill tumor progression is detecte

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 unrespectable biliary tract cancer (3)Refractory to prior both gemcitabine, TS-1 and CDDP based chemotherapy (4)Measurable disease as defined by Revised RECIST guideline (version 1.1) (5)ECOG PS of 0 or 1 (6)No severe organ function impairment (7)Life expectancy > 3 months (8)Sufficient oral intake (9)Written informed consent (10)Aged over 20 with judgment

Exclusion criteria

Exclusion criteria: (1)Previous history of chemotherapy with anti-EGFR antibody (2)Tumor is controllable with any other therapy (SD, PR, CR, NE in RECIST ver.1.1) (3)Previous history of infusion reaction by antibody drug (4)Serious complications (e.g. severe hypertension, severe heart failure, severe coronary artery disease, myocardial infarction within 3 months, severe hepatic failure, poorly controlled diabetes, plumonary fibrosis, interstitial pneumonia or renal failure with dialysis) (5) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy (6)Pregnant or lactating women or women of childbearing potential (restrict lactating within 8 weeks after last Panitmumab administration) (7)Patient with severe drug allergy (8)Psychosis or severe mental disorder (9)Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
response rate (CR+PR)	—

Secondary

Measure	Time frame
Severe adverse events Progression free survival (PFS) Time to progression (TTP) Overall survival (OS) Median survival time (MST) Disease control rate (DCR) adverse events	—

Countries

Japan

Contacts

Public ContactHiroki Hayashi

Tohoku University Hospital Hepato-Biliary Pancreatic Surgery

hiroki@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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