Exploratory study for biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma

Exploratory study for biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma - Biomarker study of sorafenib

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000008808

Enrollment

100

Registered

2012-09-01

Start date

2012-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellulara carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are indicated for sorafenib as the treatment of advanced or recurrent hepatocellular carcinoma 2. Patients who have never used sorafenib before 3. Patients with adequate organ function (to be confirmed within 2 weeks before the start of study treatment) a. Neutrophil count >1000 b. Platelets >50000 c. Hemoglobin >8.0 d. Total bilirubin <2.0 mg/dL e. Serum aspartate aminotransferase, serum alanine aminotransferase <200 IU/L 4. Child-Pugh score <8 5. Patients who have given written informed consent

Exclusion criteria

Exclusion criteria: 1. Ineligible for dynamic CT or MRI; 2. Patients with cerebral metastasis; 3. Pregnant and breastfeeding women or those who may possibly be pregnant; 4. Patients with uncontrollable hypertension (BP>170 mmHg under medication) or with thromboembolism, ischemic heart disease, unstable angina pectoris, heart failure, or cerebrovascular disorder; 5. Patients with moderate or severe renal dysfunction (Ccr < 30 mL/min) including those on dialysis; 6. Patients with esophageal varices that may cause bleeding (those who had gastrointestinal bleeding in the past month); 7. Patients under treatment with drugs affecting the activity of CYP3A4 or UGT1A9 (e.g., carbamazepine, rifampicin, St. John's wort, etc. ) or drugs that may affect the serum concentration of sorafenib; 8. Patients with diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); or 9. Patients judged as ineligible by the investigator in charge for other reasons

Design outcomes

Primary

Measure	Time frame
To evaluate correlation between genome/protein/metabolites biomarker candidate and efficacy/incidence of adverse events	—

Countries

Japan

Contacts

Public ContactShunsuke Kondo

National Cancer Center Hospital Internal medicine

shkondo@ncc.go.jp03-3542-2511

Outcome results