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Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

numbers of adverse events

Outcome Description:

to evaluate the toxicity of sorafenib in combination with zoledronic acid

Outcome Time Frame:

1 year

Safety Issue:

Yes

Authority:

China: Ethics Committee

Study ID:

SRFB-021

NCT ID:

NCT01259193

Start Date:

October 2010

Completion Date:

July 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Sorafenib
  • Zoledronic Acid
  • toxic reaction
  • Carcinoma
  • Carcinoma, Hepatocellular

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