Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed B… (NCT00335829) | Clinical Trial Compass
CompletedPhase 2
Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
United States26 participantsStarted 2006-05
Plain-language summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together with chemoembolization may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed\* hepatocellular carcinoma
* Unresectable disease
* Child's class A or B with liver-predominant and asymptomatic extrahepatic disease NOTE: \*A highly suspicious liver mass on CT scan or MRI in the presence of alpha fetoprotein \> 200 mg/dL may be used as alternative diagnostic criterion
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 50,000/mm³
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5.0 times upper limit of normal (ULN)
* Bilirubin ≤ 5.0 mg/dL
* Creatinine normal OR creatinine clearance \> 50 mL/min
* No significant traumatic injury within the past 28 days
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No serious, nonhealing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
* No major surgery or open biopsy within the past 28 days
* No minor surgery (e.g., fine-needle aspirations or core biopsies) within the past 7 days
* No chemotherapy within the past 4 weeks
* No radiotherapy within the past 21 days
* No concurrent major surgery
* No other concurrent chemotherapy
* No other concurrent investigational drugs
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median Progression-free Survival
Timeframe: Time through study completion, an average of 1 year
2
Time to Tumor Progression (TTP) of Targeted Lesions