Clinical trial · Interventional
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial.
- 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)
A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, capecitabine, gemcitabine, cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm chemotherapy treatment
- interventionNames
- Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
- Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 6 months after last patient included
- description
- Time from treatment start to progression or death.
Secondary outcomes (3)
- measure
- Response rate.
- timeFrame
- 6 months after last patient included
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:• Informed consent * Age \> 18 years * Performance status 0-1; expected survival ≥ 3 months * Patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma * Liver metastases not suitable for surgery or other local treatment * Extrahepatic disease should be excluded by PET-CT-scan. * Prior treatment with chemotherapy or no progression on first line treatment * Metastases \< 70 % of the liver * neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l * bilirubin \< 2.0 x UNL (upper normal limit). * creatinine-clearance ≥ 30 ml/min. * INR \< 2. * Intrahepatic treatment can be accomplished * The patients is approved by a multidisciplinary team Exclusion Criteria:• Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin. * Cytotoxic or experimental treatment within a 14 days period before start of trial medication * The patient is not allowed to participate in other clinical trials. * Any clinical symptoms suggesting peripheral neuropathy grade 2 * Other severe medical conditions * Severe cardial disease or AMI \< 1 year * Presence of diseases preventing oral therapy * Patients with uncontrolled infection * Pregnant or lactating women * Women capable of childbearing not using a sufficient method of birth control * Patients not able to understand the treatment or to collaborate * Prior serious or unsuspected reaction after treatment with fluoropyrimidine * Known prior hypersensitivity reactions to the agents * Interstitial pneumonitis or pulmonary fibrosis
References
Publications (0)
Data not yet available