Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Fudan University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01259193
First received: December 13, 2010
Last updated: April 13, 2011
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: Sorafenib and Zoledronic Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC |
Resource links provided by NLM:
Further study details as provided by Fudan University:
Primary Outcome Measures:
- numbers of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]to evaluate the toxicity of sorafenib in combination with zoledronic acid
Secondary Outcome Measures:
- Overall survival (OS), time to progression (TTP) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]to evaluate the efficacy of sorafenib in combination with zoledronic acid
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sorafenib and Zoledronic Acid |
Drug: Sorafenib and Zoledronic Acid
Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259193
Contacts
| Contact: Zheng-Gang Ren, Ph.D | 0086-021-64041990 ext 2149 | ren.zhenggang@zs-hospital.sh.cn |
| Contact: Lan Zhang, Master | 0086-021-64041990 ext 2171 | zhang.lan@zs-hospital.sh.cn |
Locations
| China, Shanghai | |
| Liver Cancer Institute | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Zheng-Gang Ren, Ph.D 0086-021-64041990 ext 2137 ren.zhenggang@zs-hospital.sh.cn | |
| Contact: Lan Zhang, Master 0086-021-64041990 ext 2171 zhang.lan@zs-hospital.sh.cn | |
| Principal Investigator: Zheng-Gang Ren, Ph.D | |
| Sub-Investigator: Jubo Zhang, PhD | |
Sponsors and Collaborators
Fudan University
More Information
Additional Information:
No publications provided
| Responsible Party: | Ren Zhenggang/Professor Sun Huichuan/Professor, Shanghai Zhongshan Hospital,China |
| ClinicalTrials.gov Identifier: | NCT01259193 History of Changes |
| Other Study ID Numbers: | SRFB-021, LCI-10-10-20 |
| Study First Received: | December 13, 2010 |
| Last Updated: | April 13, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
Hepatocellular Carcinoma Sorafenib Zoledronic Acid toxic reaction |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Zoledronic acid Diphosphonates Sorafenib Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013