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

NCT02425605 | Completed Phase 2

• 1 other identifier: 4-2014-0803
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  36 months after the enrollment

Secondary Outcomes (4)

• PFSL defined as dynamic CT scan

  36 months after the enrollment

• PFSO defined as definitive imaging technique

  36 months after the enrollment

• tumor response defined as modified RECIST

  36 months after the enrollment

• toxicity defined as NCI-CTC(version 4.02)

  36 months after the enrollment

Study Arms (1)

CCRT-sorafenib group

EXPERIMENTAL

Radiation: CCRT; Drug: sorafenib

Interventions

CCRT RADIATION

The subject is treated with a total of 45 Gy of external beam radiotherapy (1.8 Gy per session, 5 sessions a week, for 5 weeks), with hepatic arterial infusion of 5-flourouracil (5-FU) during the first and last 5 days of radiation therapy (5-FU 500 mg infusion for 5 hours) for radiosensitization through the pre-inserted chemoport.

Also known as: Localized concurrent chemoradiation therapy(CCRT)

CCRT-sorafenib group

sorafenib DRUG

Four weeks after completion of CCRT, the subject is given daily sorafenib treatment and will be followed for survival.

Also known as: sorafenib(Nexavar®) sequential therapy

CCRT-sorafenib group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Beom Kyung Kim, M.D., Ph.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 24, 2015
• Study Start: December 3, 2014
• Primary Completion: September 22, 2017
• Study Completion: September 22, 2017
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

KR (1)