NCT01259193UnknownPhase 2
Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Fudan University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- numbers of adverse events
Study Overview
Brief Summary
Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.
Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.
The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- •patient with unresectable primary hepatocellular carcinoma
- •Child-Pugh Class A or B, score ≤ 7
- •ECOG score 0-2
- •Expected survival time not less than 12 weeks
- •At least one tumor nodule with one uni-dimension of ≥ 1 cm
- •Peripheral platelet of or more than 50×10(9)/L
- •Peripheral hemoglobin of or more than 85g/L
- •Peripheral albumen of or more than 28g/L
- •Total bilirubin ≤3.0mg/dl
- •ALT and AST ≤ 5.0 x the upper limit of normal
- •Serum amylase ≤ 1.5x the upper limit of normal
- •Serum creatinine ≤ 1.5x upper limit of normal
- •PT-INR<2.3 or PT prolong no more than 4s of normal
Exclusion Criteria
- •Congestive heart failure > NYHA class 2
- •History of active coronary disease( except myocardial infarction more than 6 months ago)
- •Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
- •uncontrollable hypertension
- •Active clinically serious infections (> 2 NCI-CTC Version 3.0)
- •History of HIV infection
- •Inclined to hemorrhage or active hemorrhage with 1 month
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
- •Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
- •Known or suspected allergy to any agent given in association with this trial
- •Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
- •Surgical operation within 4 weeks prior to enrolling in this portion of the study
Arms & Interventions
Sorafenib and Zoledronic Acid
Experimental
Intervention: Sorafenib and Zoledronic Acid (Drug)
Outcomes
Primary Outcomes
numbers of adverse events
Time Frame: 1 year
to evaluate the toxicity of sorafenib in combination with zoledronic acid
Secondary Outcomes
- Overall survival (OS), time to progression (TTP)(1 year)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Suspended
Phase 1
Sorafenib in Combination With RAD001 in Advanced Solid Tumors Selected on Molecular TargetsAdvanced Solid TumorsNCT01226056Southern Europe New Drug Organization45
Active, not recruiting
Not Applicable
A Phase II Trial of Sorafenib (a tyrosine kinase inhibitor) given orally twice daily in renal cancer patients with vHL syndrome - Oral Sorafenib in renal cancer patients with vHL syndromevon Hippel Lindau syndrome (vHL) is a rare genetic disorder that causes a predisposition to develop multiple tumours, including renal, CNS and retinal tumours. vHL patients who have solid renal tumours (< or =2.4 cm) will require surgery to remove the renal tumours once they reach 2.5cm or greater. Disease-stabilising agents such as sorafenib could potentially delay or avoid the need for surgery.MedDRA version: 9.1Level: LLTClassification code 10047716Term: Von Hippel-Lindau diseaseEUCTR2007-002132-29-GBOxford Radcliffe Hospitals NHS Trust25
Terminated
Phase 2
Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast CancerBreast CancerNCT00525161Suleiman Massarweh11
Unknown
Phase 2
Study of PolyIC and PD-1 mAb in Subjects With Unresectable Hepatocellular CarcinomaCarcinoma, HepatocellularNCT03732547Second Affiliated Hospital, School of Medicine, Zhejiang University60
Completed
Phase 2
Study Evaluating Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Less Than 60 Years of AgeAcute Myeloid Leukemia (AML)NCT00893373Technische Universität Dresden276