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

Primary Purpose

Hepatocellular Carcinoma, Portal Vein Tumor Thrombosis

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Scheduled interval TACE - RT

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring RT, TACE

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Patients must have a diagnosis of PVTT 2.1 Early arterial enhancement and delayed washout on multiphasic CT or MRI
Eastern cooperative oncology group performance status 0 1 2
Age ≥ 20 and 70 or less
Unsuitable for resection or transplant or radiofrequency ablation (RFA)
Unsuitable for or refractory to TACE or drug eluting beads (DEB)
Agreement of study-specific informed consent
Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
Child-Pugh score A-B within 7 days prior to study entry
Normal liver (Liver minus gross tumor volume) ≥ 700 cc
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
Male, consent contraception at least 6 months
Childbearing potential woman, consent contraception at least 6 months
Life expectancy more than 12 weeks
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

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scheduled TACE-RT

Arm Description

RT will be delivered at two weeks after TACE for HCC combined PVTT.

Outcomes

Primary Outcome Measures

Overall survival rate after scheduled TACE-RT for HCC with PVTT

Overall survival rate will be evaluated at 1 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

Adverse event will be evaluated at 3 months after treatment.

Secondary Outcome Measures

Radiologic response assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST) after scheduled TACE-RT for HCC with PVTT

Radiologic response will be evaluated at 3 months after treatment.

Full Information

NCT ID

NCT02290977

First Posted

November 6, 2014

Last Updated

December 3, 2014

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02290977

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Portal Vein Tumor Thrombosis

Keywords

RT, TACE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Scheduled TACE-RT

Arm Type

Experimental

Arm Description

RT will be delivered at two weeks after TACE for HCC combined PVTT.

Intervention Type

Radiation

Intervention Name(s)

Scheduled interval TACE - RT

Intervention Description

RT will be administered at 2 weeks after TACE in HCC combined PVTT

Primary Outcome Measure Information:

Title

Overall survival rate after scheduled TACE-RT for HCC with PVTT

Description

Overall survival rate will be evaluated at 1 year after treatment.

Time Frame

One year after treatment

Title

Adverse event assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 after scheduled TACE-RT for HCC with PVTT

Description

Adverse event will be evaluated at 3 months after treatment.

Time Frame

Three months after treatment

Secondary Outcome Measure Information:

Title

Radiologic response assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST) after scheduled TACE-RT for HCC with PVTT

Description

Radiologic response will be evaluated at 3 months after treatment.

Time Frame

Three months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Patients must have a diagnosis of PVTT 2.1 Early arterial enhancement and delayed washout on multiphasic CT or MRI Eastern cooperative oncology group performance status 0 1 2 Age ≥ 20 and 70 or less Unsuitable for resection or transplant or radiofrequency ablation (RFA) Unsuitable for or refractory to TACE or drug eluting beads (DEB) Agreement of study-specific informed consent Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry? Child-Pugh score A-B within 7 days prior to study entry Normal liver (Liver minus gross tumor volume) ≥ 700 cc 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 Male, consent contraception at least 6 months Childbearing potential woman, consent contraception at least 6 months Life expectancy more than 12 weeks 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yong Han Paik, Professor

Phone

82-2-3410-2612

yh.paik@samsung.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ju Yeon Cho, MD

Phone

82-2-3410-2612

juyeon.cho@samsung.com

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact: