Efficacy of Localized Concurrent Chemo-radiation Therapy and Sorafenib Sequential Therapy in Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2017-09-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, single-arm, open-label, prospective phase 2 trial to assess the efficacy of localized concurrent chemoradiation therapy (CCRT) and sorafenib sequential therapy in subjects with advanced HCC. Approximately 47 subjects will be enrolled and will receive CCRT and sorafenib sequentially until all-cause mortality.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Subjects must have confirmed diagnosis of unresectable hepatocellular carcinoma (HCC) categorized to stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system with any of following criteria: 1) Lesion limited to a single lobe that is within the radiotherapy field, 2) Lesion not limited to a single lobe, but the lesion that is not within the radiotherapy field can be controlled by transarterial chemoembolization or radiofrequency ablation, 3) Presence of metastatic lesions that measure < 1.0 cm in the long axis, 4) The lesion can be accurately measured in at least one dimension as ≥ 1.0 cm

• Males or females aged at least 20 years and below 76 years

• Eastern Cooperative Oncology Group performance status (ECOG-PS) 0 or 1

• Adequate liver function, defined as: 1) Child-Pugh score ≤ 7, 2) Bilirubin ≤ 3.0 mg/dL

• Adequate bone marrow function, defined as: 1) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, 2) White blood cell count (WBC) ≥ 4.0 × 109/L, 3) Platelet count ≥ 60 × 109/L

• Adequate renal function, defined as serum creatinine < 2.0 mg/dL

• Subjects with hepatitis B virus (HBV)-related HCC must have adequately controlled HBV replication status

• Adequate blood coagulation factors, defined as international normalized ratio (INR) ≤ 2.3

• Provide written informed consent

• Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

• Significant liver function impairment, defined as bilirubin > 3.0 mg/dL or uncontrolled ascites

• Imaging findings for HCC corresponding to any of the following: 1) Diffuse HCC with > 50% liver occupation, that is not adequate for external radiotherapy, 2) Presence of metastatic lesions that measure ≥ 1.0 cm in the long axis

• Uncontrolled significant active infection

• Presence of active malignancy (except for HCC)

• Females who are lactating or pregnant; females of childbearing potential who have not received pregnancy test or shown positive on pregnancy test

• Any medical or other condition that in the opinion of the investigator would preclude the subject's participation in a clinical study

• Major surgery within 4 weeks prior to enrollment