Clinical trial · Interventional
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
NCT00747097CI-TRIAL-00004405ECHOcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Time to Progression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine + cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- gemcitabine+cetuximab
- interventionNames
- Drug: gemcitabine + cetuximab
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- overall survival, objective response, safety
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract * signed written informed consent * age \> 18 * WHO PS 0 or 1 at study entry * measurable (diameter ³ 1 cm) / evaluable disease, according to RECIST criteria * adequate renal (serum creatinin\<1.5x upper reference range), liver (total bilirubin\<2x upper reference range) and hematopoietic functions (PMN\>1,5x109/L, platelets\>100x109/L) * life expectancy of at least 12 weeks * effective contraception throughout the study for both male and female patients if the risk of conception exists Exclusion Criteria: * uncontrolled concurrent CNS, cardiac, infectious diseases * previous exposure to epidermal growth factor targeting therapy * known hypersensitivity to any components of study treatments * previous chemotherapy for this cancer * previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix * pregnancy or breast feeding * medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
References
Publications (1)
- DERIVEDBorbath I, Ceratti A, Verslype C, Demols A, Delaunoit T, Laurent S, Deleporte A, Vergauwe P, Van Maanen A, Sempoux C, Van Cutsem E, Van Laethem JL; Belgian Group of Digestive Oncology. Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: a phase II study of the Belgian Group of Digestive Oncology. Ann Oncol. 2013 Nov;24(11):2824-9. doi: 10.1093/annonc/mdt337. Epub 2013 Aug 23. PMID 23975665