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

NCT02290977 | Unknown Phase 2 DMC

• 1 other identifier: 2014-07-009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Portal Vein Tumor Thrombosis

Keywords

RT, TACE

Outcome Measures

Primary Outcomes (2)

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

  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

  Adverse event will be evaluated at 3 months after treatment.

  Three months after treatment

Secondary Outcomes (1)

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

  Three months after treatment

Study Arms (1)

Scheduled TACE-RT

EXPERIMENTAL

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

Radiation: Scheduled interval TACE - RT

Interventions

Scheduled interval TACE - RT RADIATION

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

Scheduled TACE-RT

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Central Study Contacts

Yong Han Paik, Professor

CONTACT

82-2-3410-2612; yh.paik@samsung.com

Ju Yeon Cho, MD

CONTACT

82-2-3410-2612; juyeon.cho@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 14, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

KR (1)