MedPath

Identification of predictive biomarkers for treatment outcome in patients with advanced hepatocellular carcinoma

Not Applicable
Recruiting
Conditions
Diseases of the digestive system
Registration Number
KCT0002264
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

? unresectable primary liver cancer
? Age 20 years old or older
? Whole body performance (ECOG) 0-2
? Child-Pugh score is B or more
? Minimum volume of normal liver without tumor invasion> 1000cm3
? Minimum distance between target and organ at risk (eg duodenum, stomach) = 0.5cm
? Adequate *LFT (*AST / *ALT <5 x upper limit of normal, total bilirubin> <3 mg / dl, albumin> 2.5 g / dL, normal *PT / *PTT)
? Adequate renal function (creatinine <1.8 mg / dl or *Ccr> 50 ml / min)
? *BM reserve (*ANC =1500 / mm3, *PLT =50000 / mm3, *Hb> 9 g / dl)
? lesion that can be measured or evaluated on CT
? Those who are pregnant and who agree to contraception
? The person who can read and understand the research agreement and sign the study agreement.

*LFT(liver function test)
*AST(aspartate aminotransferase)
*ALT(alanine Transaminase)
*PT(Prothrombin Time)
*PTT(Partial Thromboplastin Time)
*BM(Bone Marrow)
*ANC(Absolute Neutrophil Count)
*PLT(Platelet count)
*Hb(Hemoglobin)
*Ccr(Creatinine clearance)

Exclusion Criteria

? Those who can not perform respiratory training for treatment design
? Patients with a history of previous abdominal radiation therapy
? Those who can not receive consent before treatment
? Those who do not agree to contraception as a pregnant patient

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The association of serum cytokines with pre-selected live markers (usefulness test)
Secondary Outcome Measures
NameTimeMethod
The relationship between the biomarker selected as the predictive model and the treatment performance (designing the risk prediction model)
© Copyright 2025. All Rights Reserved by MedPath