Clinical trial · Interventional
Sorafenib Tosylate in Treating Patients With Liver Cancer That Can Be Removed by Surgery
Proof-of-Concept Phase II Study to Evaluate the Anti-Tumor Activity of Sorafenib Along With Pathological and Molecular Changes in Tumor Samples From Patients With Resectable 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: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating patients with liver cancer that can 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Antiangiogenic effects of sorafenib tosylate
- measure
- Significant pathological changes
Secondary outcomes (6)
- measure
- Pathologic findings in sorafenib tosylate pre-treated patients undergoing surgical resection for hepatocellular carcinoma
- measure
- Number of R0 resections
- measure
- Correlations between baseline patient characteristics, cancer biomarkers, and outcome variables and resected tumors
- measure
- Plasma biomarkers at baseline, day 28, and the day before surgery
- measure
- Safety profile of sorafenib tosylate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed hepatocellular carcinoma (HCC) * Fibrolamellar or mixed histology allowed * No cholangiocarcinoma or other tubal disease * Must be eligible for conservative hepatic resection or liver resection with curative intent * No cirrhosis with Child-Pugh score \> 7 * Chronic liver disease without liver insufficiency and without portal liver hypertension allowed * No known history or presence of metastatic brain or meningeal tumors PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 3 months * WBC \> 3,000/µL * ANC \> 1,500/µL * Platelet count ≥ 100,000/µL * Hemoglobin ≥ 9 g/dL * Bilirubin \< 1.5 times upper normal limit (ULN) * AST and ALT ≤ 5 times UNL * Alkaline phosphatase ≤ 5 times ULN * Serum creatinine \< 2 times ULN * PT/INR/PTT \< 1.5 times UNL * Amylase and lipase \< 1.5 times ULN * Negative pregnancy test * Fertile patients must use effective contraception * Body mass index 18.5-30 kg/m\^2 (WHO normal range: 18.5-25 kg/m\^2) * Able to swallow oral compound * No criterion for unresectability or medical condition that contraindicates surgical resection * No serious concurrent systemic disorder incompatible with the study, including any of the following: * Uncontrolled hypertension (i.e., BP \> 150/100 mm Hg despite optimal therapy) * Active uncontrolled infection * Active alcoholism * No prior medical disorder, including any of the following: * Cardiac arrhythmias requiring anti-arrhythmics (excluding beta-blockers or digoxin for chronic atrial fibrillation) * Active coronary artery disease or ischemia * Myocardial infarction within the past 6 months * NYHA class III-IV congestive heart failure * Pulmonary embolism within the past 6 months * Gastrointestinal bleeding within the past 6 months * No other prior malignancy within the past 5 years, except basal cell or squamous cell skin carcinoma or cured in situ cervical carcinoma * No history or concurrent seizure disorder requiring medications (e.g., antiepileptic drugs) * No history of HIV infection, or chronic hepatitis B or C * No active clinically serious bacterial or fungal infection (i.e., grade 2 CTCAE v. 3) * No condition that is unstable or could jeopardize the safety of the patient and his/her compliance with the study * No substance abuse or medical, psychological, or social condition that could interfere with adherence to the study * No known or suspected allergy to the investigational agent or to any agent given concurrently * No presence of asthenia or rash \> CTC grade 1 at enrollment * Must be registered in a national health-care system PRIOR CONCURRENT THERAPY: * No prior orthotopic liver transplantation * Not a candidate for orthotopic liver transplantation * No prior systemic or loco-regional treatment for HCC * No prior organ allograft * No treatment with any other investigational medicinal product within the past 28 days * No concurrent treatment with full-dose anticoagulants * Deep-vein or catheter-associated thrombosis prophylaxis allowed * Warfarin or heparin therapy allowed if the coagulation parameters were within the acceptable ranges prior to initiation of anticoagulant therapy * No concurrent or chronic co-administration of CYP3A4 inducers (e.g., rifampin, Hypericum perforatum, phenytoin, carbamazepine, phenobarbital, or dexamethasone)
References
Publications (0)
Data not yet available