Clinical trial · Interventional
Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients
- 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 cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib 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. Infusing chemotherapy directly into the liver and giving it together with sorafenib may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or carboplatin directly into the liver and giving it together with sorafenib in treating patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin or Carboplatin + Sorafenib
- interventionNames
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Number of Subjects Experiencing Adverse Events
- timeFrame
- 36 months
- description
- The number of subjects experiencing adverse events after receiving protocol therapy.
Secondary outcomes (1)
- measure
- Number of Patients Achieving Clinical Benefit
- timeFrame
- 36 months
- description
- Number of patients achieving complete or partial response according to RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed hepatocellular carcinoma (HCC) OR serum alpha fetoprotein ≥ 400 ng/mL with radiological evidence suggestive of HCC * Unresectable disease * Child-Pugh class A or selected Child-Pugh class B disease (Child-Pugh score ≤ 7 points) * No Child-Pugh class C disease * No disease outside the liver or macroscopic invasion of the major vessels such as the portal vein * No known brain metastasis * Patients with neurological symptoms must undergo CT scan or MRI of the brain PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,000/mm³ (for patients scheduled to receive carboplatin) or ≥ 2,000/mm³ (for patients scheduled to receive cisplatin) * Platelet count ≥ 100,000/mm³ (for patients scheduled to receive carboplatin) or ≥ 60,000/mm³ (for patients scheduled to receive cisplatin) * Serum creatinine ≤ 1.9 mg/dL (for patients scheduled to receive carboplatin) or ≤ 1.5 mg/dL (for patients scheduled to receive cisplatin) * Serum total bilirubin ≤ 3 mg/dL * AST and ALT \< 5 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No cardiac disease, including any of the following: * NYHA class III-IV congestive heart failure * Unstable angina (anginal symptoms at rest) * New onset of angina within the past 3 months * Myocardial infarction within the past 6 months * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * No uncontrolled hypertension, defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management * No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months * No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks * No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks * No evidence or history of bleeding diathesis or coagulopathy * No evidence of encephalopathy * No condition that would impair the ability to swallow whole pills * No history of malabsorption problems * No significant traumatic injury within the past 4 weeks * No serious non-healing wound, ulcer, or bone fracture * No active clinically serious infection * No known HIV infection * No known or suspected allergy to sorafenib tosylate or any other study agent PRIOR CONCURRENT THERAPY: * No prior cisplatin, carboplatin, or sorafenib tosylate * No prior systemic chemotherapy for HCC * No other prior systemic or locoregional therapy * More than 4 weeks since prior major surgery or open biopsy * No concurrent St. John's wort or rifampin
References
Publications (0)
Data not yet available