Transarterial Chemoembolization (TACE) With Radiation Therapy (RT) in Advanced Hepatocellular Carcinoma (HCC)

December 3, 2014 updated by: Paik Yong Han, Samsung Medical Center

Scheduled Interval Trans-catheter Arterial Chemo-embolization and Radiation Therapy for Hepatocellular Carcinoma Combined With Portal Vein Tumor Thrombosis: Prospective Phase II Trial

The presence of portal vein tumor thrombosis (PVTT) in patients with hepatocellular carcinoma (HCC) is one of the most significant prognostic factors for poor prognosis, without treatment, their survival is less than 3 months. In the HCC patients who combined with PVTT, Radiation therapy (RT) showed 50% of local control and about 10 months survival duration. Despite the standard treatment of the HCC combined with PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an alternative option in those patients. Investigators previously reported the retrospective study that the scheduled interval Trans-catheter Arterial Chemo-embolization (TACE) followed by RT for HCC combined with PVTT and 60% of the patients showed objective response without significant elevation of complication. However, the prospective outcomes of TACE followed by RT for HCC are scantly reported. Based on those background, we start this prospective study to evaluate the clinical outcomes and adverse event in the RT after TACE in the unresectable HCC patients who combined with PVTT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Yong-Han Paik, MD, PhD
        • Sub-Investigator:
          • Hee Chul Park, MD, PhD
        • Sub-Investigator:
          • Ju-Yeon Cho, MD
        • Sub-Investigator:
          • Jeong Il Yu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients must have a diagnosis of HCC by at least one criterion listed below (korean liver cancer study group (KLCSG) guideline 2009) 1.1 Pathologically (histologically or cytologically) proven diagnosis of HCC 1.2 Liver nodule in high risk group 1.2.1 If alpha fetoprotein (AFP) ≥200 ng/mL , ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI 1.2.2 If AFP<200 ng/mL, ≥2 typical HCC enhancing pattern on dynamic contrast enhanced CT, MRI, and angiography 1.3 ≥ 2 cm nodule in liver cirrhosis (LC), ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI
  2. Patients must have a diagnosis of PVTT 2.1 Early arterial enhancement and delayed washout on multiphasic CT or MRI
  3. Eastern cooperative oncology group performance status 0 1 2
  4. Age ≥ 20 and 70 or less
  5. Unsuitable for resection or transplant or radiofrequency ablation (RFA)
  6. Unsuitable for or refractory to TACE or drug eluting beads (DEB)
  7. Agreement of study-specific informed consent
  8. Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
  9. Child-Pugh score A-B within 7 days prior to study entry
  10. Normal liver (Liver minus gross tumor volume) ≥ 700 cc

  11. Blood work requirements

    • Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 70,000/mm3, Hgb ≥ 8 g/dl
    • Liver function test (LFT): Total bilirubin<3.0 mg/dL, International normalized ratio(INR) < 1.7, Albumin ≥ 2.8g/dL, Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT)< 6 X normal
    • Serum creatinine < 1.5 X normal, or creatinine clearance ≥ 60 mL/min
  12. Male, consent contraception at least 6 months
  13. Childbearing potential woman, consent contraception at least 6 months
  14. Life expectancy more than 12 weeks
  15. Stable breathing more than 5 minutes

Exclusion Criteria:

  • 1. Complete obstruction of main portal vein 2. Pregnant and/or breastfeeding woman 3. Previous upper abdominal RT history 4. Uncontrolled active co-morbidity 5. Another primary cancer history within 2 years 6. Uncontrolled ascites or hepatic encephalopathy 7. Connective tissue disease which known as radiation hypersensitivity 8. Uncontrolled moderate to severe gastroduodenal ulcer or esophagogastric varices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scheduled TACE-RT
RT will be delivered at two weeks after TACE for HCC combined PVTT.
Radiation: Scheduled interval TACE - RT
RT will be administered at 2 weeks after TACE in HCC combined PVTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate after scheduled TACE-RT for HCC with PVTT
Time Frame: One year after treatment
Overall survival rate will be evaluated at 1 year after treatment.
One year after treatment
Adverse event assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 after scheduled TACE-RT for HCC with PVTT
Time Frame: Three months after treatment
Adverse event will be evaluated at 3 months after treatment.
Three months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiologic response assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST) after scheduled TACE-RT for HCC with PVTT
Time Frame: Three months after treatment
Radiologic response will be evaluated at 3 months after treatment.
Three months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-07-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Scheduled interval TACE - RT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe