Clinical trial · Interventional
Bevacizumab in Treating Patients With Unresectable Nonmetastatic Liver Cancer
Bevacizumab (RhuMAB-VEGF) In Hepatocellular Cancer For Patients With Unresectable Tumor (Without Invasion Of The Main Portal Vein Or Metastatic Disease) A Phase II Study
- 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)
This phase II trial is to see if bevacizumab works in treating patients who have unresectable nonmetastatic liver cancer that has not spread to the main portal vein. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bevacizumab)
- description
- Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: bevacizumab
Primary outcomes (5)
- measure
- Progression-free Survival
- timeFrame
- At 6 months
- measure
- Disease Response
- timeFrame
- MRI is required at weeks 8, 16 and then every 12 weeks until disease progression
- description
- MRI scan is required at weeks 8, 16 and then every 12 weeks until disease progression. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed hepatocellular carcinoma * Confirmed by needle aspirate, biopsy, or prior surgical resection specimen * Clinically confirmed hepatocellular carcinoma defined as follows: * Cirrhosis or chronic hepatitis B or C virus infection, with 1 or more hypervascular liver masses more than 2 cm * Alpha-fetoprotein (AFP) greater than 400 ng/mL OR greater than 3 times normal and doubling in value during the past 3 months * Deemed unresectable * Prior surgical resection allowed * Recurrence after hepatic resection or other procedure allowed * Tumor that extends into branches of the portal or hepatic veins allowed * No tumor invading the main portal vein (portal trunk) or inferior vena cava * No tumor occupying more than 50% of the liver volume * Enlargement/involvement of regional lymph nodes allowed * At least 1 unidimensionally measurable lesion at least 20 mm * No poorly defined lesions * No vague hypervascular patches * Child-Pugh class A or compensated Child-Pugh class B liver dysfunction * No Child-Pugh class C or uncompensated class B indicated by active encephalopathy, persistent ascites, or prothrombin time greater than 1.5 times normal * Prior ascites allowed if manageable with diuretics alone * No repeated paracentesis (more than 1 per month) * No extrahepatic metastasis * No documented brain metastases * No history or clinical evidence of CNS disease (e.g., primary brain tumor, seizures uncontrolled with standard medical therapy, or history of stroke) * Performance status - ECOG 0-2 * Absolute neutrophil count greater than 1,500/mm\^3 * Hemoglobin at least 8 g/dL * Platelet count at least 75,000/mm\^3 * No prior serious bleeding event (unrelated to liver disease) * No bleeding diathesis * No coagulopathy * Bilirubin no greater than 3 mg/dL * Transaminases less than 5 times upper limit of normal (ULN) * Albumin at least 2.5 mg/dL * PTT less than 4 seconds above ULN * INR less than 1.5 (for patients receiving warfarin) * Creatinine less than 1.5 g/dL * Urine protein less than 500 mg/24hrs\* Exclusion criteria: * No thromboembolic event within the past 12 months * No clinically significant cardiovascular disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring parenteral antibiotics * No serious non-healing wound/ulcer or bone fracture * No variceal bleeding within the past 6 months * No malignancy within the past 5 years except localized nonmelanoma skin cancer * No ongoing psychiatric or social situation that would preclude study compliance * No known hypersensitivity to Chinese hamster ovary cell products * No known hypersensitivity to other recombinant human antibodies * No more than 1 prior biologic therapy * No concurrent interferon * No concurrent interleukin-2 * No more than 1 prior antineoplastic chemotherapy * At least 4 weeks since prior invasive surgery, including open biopsy * At least 2 weeks since prior needle biopsy (core or fine-needle aspirate) * No concurrent hepatic transplant * At least 4 weeks since prior anticancer therapy * No concurrent platelet-stimulating factors (e.g., oprelvekin) * No concurrent full-dose anticoagulants or thrombolytic agents (except as required to maintain patency of pre-existing, permanent indwelling IV catheters) * No chronic daily antiplatelet drugs (e.g., aspirin doses of 325 mg/day or higher or non-steroidal anti-inflammatory drugs)
References
Publications (1)
- RESULTSiegel AB, Cohen EI, Ocean A, Lehrer D, Goldenberg A, Knox JJ, Chen H, Clark-Garvey S, Weinberg A, Mandeli J, Christos P, Mazumdar M, Popa E, Brown RS Jr, Rafii S, Schwartz JD. Phase II trial evaluating the clinical and biologic effects of bevacizumab in unresectable hepatocellular carcinoma. J Clin Oncol. 2008 Jun 20;26(18):2992-8. doi: 10.1200/JCO.2007.15.9947. PMID 18565886