NCT01216345 is a Phase 2 clinical trial of Cetuximab + Gemcitabine + Oxaliplatin in Unresectable, sponsored by Association of Research on the Biology of Liver Tumors.

Who is sponsoring NCT01216345?

NCT01216345 is sponsored by Association of Research on the Biology of Liver Tumors.

What drugs are being tested in NCT01216345?

Interventions in NCT01216345: Cetuximab + Gemcitabine + Oxaliplatin.

What condition does NCT01216345 study?

NCT01216345 studies Unresectable, Locally Advanced, Metastatic.

Is NCT01216345 still recruiting?

NCT01216345 is currently completed. Last updated 6 October 2010.

Last reviewed 2010-10-06 · How we verify

NCT01216345

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study

Completed Phase 2 Last updated 6 October 2010

What this trial tests

Phase 2 trial testing Cetuximab + Gemcitabine + Oxaliplatin in Unresectable in 30 participants. Completed in 1 October 2009.

Timeline

1 October 2006

Primary endpoint
1 October 2008

1 October 2009

Quick facts

Lead sponsor	Association of Research on the Biology of Liver Tumors
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Primary purpose	treatment
Enrollment	30
Start date	1 October 2006
Primary completion	1 October 2008
Estimated completion	1 October 2009
Sites	1 location across Austria

Drugs / interventions tested

Cetuximab + Gemcitabine + Oxaliplatin — full drug profile →

Conditions studied

Unresectable — all drugs for Unresectable →
Locally Advanced — all drugs for Locally Advanced →
Metastatic — all drugs for Metastatic →

Sponsor

Association of Research on the Biology of Liver Tumors

Who can join

18 and older, any sex, with Unresectable or Locally Advanced. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

best overall response (according to RECIST 1.0)
Time frame: after an average of 2 months
overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded

Sponsor's own description

The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative first line treatment of biliary tract cancer (BTC) patients.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study.
Gruenberger B, Schueller J, Heubrandtner U, Wrba F, et al · · 2010 · cited 181× · PMID 21071270 · DOI 10.1016/s1470-2045(10)70247-3
Genomics of gallbladder cancer: the case for biomarker-driven clinical trial design.
Sicklick JK, Fanta PT, Shimabukuro K, Kurzrock R. · · 2016 · cited 41× · PMID 26857926 · DOI 10.1007/s10555-016-9602-8
Promising Molecular Targets for the Targeted Therapy of Biliary Tract Cancers: An Overview.
Yang W, Sun Y. · · 2021 · cited 17× · PMID 33658799 · DOI 10.2147/ott.s297643
Expanding Horizons in Cholangiocarcinoma: Emerging Targets Beyond FGFR2 and IDH1.
Darman L, Kaurich Q, Hassan MS, von Holzen U, et al · · 2025 · PMID 41226789 · DOI 10.3390/ijms262110755

Verify or expand the search:

Other recruiting trials for Unresectable

Currently open trials in the same condition.

NCT06418061 — Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT06678659 — A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01216345 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Association of Research on the Biology of Liver Tumors
Last refreshed: 6 October 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01216345.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing