A phase II study of etoposide, oxaliplatin and capecitabine in patients with advanced hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003187-32-DK

Enrollment

Registered

2005-12-05

Start date

2005-12-19

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular carcinoma

Interventions

Trade Name: Vepesid Product Name: Vepesid Pharmaceutical Form: Capsule, soft INN or Proposed INN: etoposide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-100

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Advanced hepatocellular carcinoma Performance status 0-2 Age > 18 Life expectancy > 12 weeks Adequate liver, renal and cardiac function Negative pregnancy test for fertile women Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Prior chemotherapy within last 4 weeks Prior radiotherapy within last 4 weeks Prior immunotherapy within last 4 weeks Concurrent experimental therapy Allergy to the IMPs Known PDP defiency Other malignacy within last 5 years

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaulate the efficacy of the combination of etoposide, oxaliplatin and capecitabine in patients with advanced hepatocellular carcinoma not suitable for local treatment options;Secondary Objective: Evaulate the safety and duration of response of the combination of etoposide, oxaliplatin and capecitabine in patients with advanced hepatocellular carcinoma not suitable for local treatment options;Primary end point(s): Response rate (RECIST criteria) Toxicity (CTC v3.0 criteria) Time to progression survival	—

Measure

Time frame

Main Objective: Evaulate the efficacy of the combination of etoposide, oxaliplatin and capecitabine in patients with advanced hepatocellular carcinoma not suitable for local treatment options;Secondary Objective: Evaulate the safety and duration of response of the combination of etoposide, oxaliplatin and capecitabine in patients with advanced hepatocellular carcinoma not suitable for local treatment options;Primary end point(s): Response rate (RECIST criteria) Toxicity (CTC v3.0 criteria) Time to progression survival

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026