Clinical trial · Interventional
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
NCT00779454CI-TRIAL-00043237completedPhase 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 study is partly to continue the good experience the investigators have with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS).
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Oxaliplatin, Capecitabine, | Drug | — | UNRESOLVED |
| Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- KRAS wildtype
- interventionNames
- Drug: Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
- type
- OTHER
- label
- KRAS mutation
- description
- Inclusion has been completed in the KRAS mutation arm.
- interventionNames
- Drug: Gemcitabine, Oxaliplatin, Capecitabine,
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- Up to 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified adenocarcinoma arisen from gallbladder, extra or intrahepatic bile ducts or malignant cells consistent with the above and concomitant radiologic findings consistent with cholangiocarcinoma. * Curative treatment presently discounted (surgery, stereotactic radiotherapy, etc.) * KRAS analyzed and found wild-type (wt) or mutated * PS 0-2 * Evaluable disease according to RECIST criteria, i.e., the disease does not need to be measurable * Haematology: * ANC ≥ 1.5 x 10\^9/l * Thrombocytes ≥ 100x10\^9/l * Biochemistry: * Bilirubinaemia ≤ 3 x upper normal value * ALAT ≤ 5 x upper normal value * Creatinin ≤ upper normal value. If raised creatinin, the measured or calculated GFR must be at least 50% of the lower normal value. * Fertile women must present a negative pregnancy test and use birth control during and 3 months after treatment. The following methods are considered safe birth control: Birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid) * Oral and written informed consent Exclusion Criteria: * Chemotherapy within 4 weeks * Radiotherapy within 4 weeks * Immunotherapy within 4 weeks * Other concomitant experimental treatment * Known neuropathy ≥ grade 2 * Serious congruous medical disease * Other previous malignant disease within 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri * Previous serious and unexpected reactions to fluoropyrimidine treatment * Hypersensitivity to one or more of the active substances, auxiliary substances or fluoruracil * Patients with interstitial pneumonitis or pulmonary fibrosis
References
Publications (2)
- DERIVEDJensen LH, Andersen RF, Byriel L, Fernebro E, Jakobsen A, Lindebjerg J, Nottelmann L, Ploen J, Hansen TF. Phase II study of gemcitabine, oxaliplatin and capecitabine in patients with KRAS exon 2 mutated biliary tract cancers. Acta Oncol. 2020 Mar;59(3):298-301. doi: 10.1080/0284186X.2019.1701201. Epub 2019 Dec 14. PMID 31838939
- DERIVEDJensen LH, Lindebjerg J, Ploen J, Hansen TF, Jakobsen A. Phase II marker-driven trial of panitumumab and chemotherapy in KRAS wild-type biliary tract cancer. Ann Oncol. 2012 Sep;23(9):2341-2346. doi: 10.1093/annonc/mds008. Epub 2012 Feb 23. PMID 22367707