Clinical trial · Interventional
Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma
Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma
- 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)
RATIONALE: Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining celecoxib with epirubicin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of epirubicin when given together with celecoxib and to see how well it works in treating patients with hepatocellular carcinoma (liver 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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Maximum tolerated dose of epirubicin
- measure
- Response rate
- measure
- Survival at 6 months
- measure
- Overall survival
Secondary outcomes (3)
- measure
- Toxicity profile
- measure
- Serum vascular endothelial growth factor levels in correlation to response
- measure
- Cyclooxygenase-2 expression in tumor tissue and nonmalignant liver tissue in correlation to response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of localized or metastatic hepatocellular carcinoma (HCC) by 1 of the following: * Biopsy * Alpha-fetoprotein (AFP) measurement (greater than 400 ng/mL if hepatitis B surface antigen \[HBsAg\] is negative OR greater than 1,000 ng/mL if HBsAg is positive) * Not amenable to surgical resection or liver-directed therapy * Measurable or evaluable disease\* NOTE: \*Changes in AFP alone are not sufficient * Child-Pugh score A or B PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic * Bilirubin no greater than 3.0 mg/dL * AST no greater than 5 times upper limit of normal Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * LVEF greater than 45% by MUGA or echocardiogram Other * Not pregnant or nursing * Fertile patients must use effective contraception * No requirement for nonsteroidal anti-inflammatory drugs (NSAIDs) except low-dose (81 mg) aspirin * No known hypersensitivity to aspirin or other NSAIDs * No contraindication to cyclooxygenase-2 (COX-2) inhibitor therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No prior therapy for HCC
References
Publications (0)
Data not yet available