Clinical trial · Interventional
Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)
A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Did not meet the criteria for continuation to second stage
Summary
Brief summary (as posted)
Various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma, but response rates have been low with significant toxicity, most often due to parenchymal liver disease. The three agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as single agents, but the combination may act synergistically with an acceptable toxicity profile.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response
Secondary outcomes (3)
- measure
- Time to progression
- measure
- Safety
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein \> 400 ng/ml * PS 0-2 * Age 18-75 * Life expectancy \> 12 weeks * Normal bone marrow function (neutrophiles \> 1,5 x 109/l and platelets \> 100 x 109/l) * Bilirubin \< 2 x UNL * Transaminases \< 3 x UNL * Normal renal function, Cr-EDTA clearance \> 50 ml/min * No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion * No uncontrolled, severe concurrent medical disease * Fertile women must have a negative pregnancy test * Fertile women must use adequate contraceptives during and 3 months after trial exposure * Signed informed consent Exclusion Criteria: * Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion * Experimental therapy \< 8 weeks prior to inclusion * Known DPD-deficiency * Known neuropathy * Uncontrolled, severe concurrent medical disease * Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
References
Publications (0)
Data not yet available