Clinical trial · Interventional
Combination Chemotherapy and Interferon Alfa-2b in Treating Patients With Nonmetastatic Liver Cancer That Cannot Be Removed by Surgery
A Phase II Trial of Oxaliplatin/Adriamycin/5 Fluorouracil in Continuous Infusion / Interferon α-2b (OXAFI) Combination as Neoadjuvant Therapy in Unresectable Non-Metastatic 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: Drugs used in chemotherapy, such as oxaliplatin, doxorubicin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy together with interferon alfa may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with interferon alfa-2b works in treating patients with nonmetastatic liver cancer that cannot be removed by surgery.
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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| biopsy | Procedure | — | UNRESOLVED |
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective tumor response rate as measured by RECIST criteria
Secondary outcomes (2)
- measure
- Serum VEGF levels
- measure
- Tissue VEGF expression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatocellular carcinoma * Advanced, unresectable, nonmetastatic disease * Multifocal disease within the same lobe of the liver allowed * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * No intractable ascites that cannot be controlled by medical therapy * No extrahepatic metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * WBC ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Bilirubin ≤ 2.9 mg/dL * AST and ALT ≤ 5 times upper reference range (URR) * Albumin \> 30 g/L * Creatinine ≤ 1.5 times URR * Creatinine clearance \> 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study therapy * No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix * No concurrent substantial medical illness, such as cardiac or renal disease * MUGA heart study normal * No history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study * No history of autoimmune disease * No thyroid dysfunction * No active hepatitis B or C flare or chronic active hepatitis * Hepatitis B surface antigen (HBsAg) status known * If HBsAg is negative, anti-HBc antibodies should be tested; if anti-HBc is positive, then hepatitis B virus (HBV) DNA detection should be performed to discern presence of mutant HBV carriage * No alcohol or drug abuse * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No psychiatric illness or social situation that would preclude study compliance * Patients with a history of depression or psychiatric disorders are ineligible PRIOR CONCURRENT THERAPY: * No prior chemotherapy and/or radiotherapy * No other concurrent investigational agents
References
Publications (1)
- RESULTAng MK, Poon D, Foo KF, Chung YF, Chow P, Wan WK, Thng CH, Ooi L. A new chemoimmunotherapy regimen (OXAFI) for advanced hepatocellular carcinoma. Hematol Oncol Stem Cell Ther. 2008 Jul-Sep;1(3):159-65. doi: 10.1016/s1658-3876(08)50024-0. PMID 20063546