Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Chlorotrianisene

Liver Extracts

Intervention:

Yttrium-90 Transarterial Radioembolization

* Patients with measurable, locally advanced HCC those are not suitable to have or have failed potentially curable intervention (Radio frequency ablation for small tumor, resection or transplantation).
* The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection.
* Patients must not be less than 18 and not more than 80 and can be either gender.
* Patients must have a performance status of ECOG score equal to or less than 2.
* Child-Pugh's A or Early B, score 8 and above

Intervention:

Trans-arterial chemo-embolization using Drug-eluting beads

* Patients with measurable, locally advanced HCC those are not suitable to have or have failed potentially curable intervention (Radio frequency ablation for small tumor, resection or transplantation).
* The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection.
* Patients must not be less than 18 and not more than 80 and can be either gender.
* Patients must have a performance status of ECOG score equal to or less than 2.
* Child-Pugh's A or Early B, score 8 and above

Yttrium-90 radioembolization (90Y) is a relatively new technique involving the trans-arterial administration of glass or resin microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.

Transarterial Radioembolization

TACE is a procedure in which a catheter is introduced into the branches of the hepatic artery supplying the tumor. Embolic material and chemotherapeutic agents are deployed through the catheter directly into the tumor vasculature. This technique potentially enhances the cytotoxic effect by inducing ischemia and retention of the therapeutic agent in the vicinity of the tumor.

The drug-eluting beads (DEBs) enable standardization of TACE since DEBs act as both an occluding agent as well as a drug-loaded carrier, achieving local ischemia and cytotoxic death of the tumor with one device.

Transarterial Chemoembolization using drug-eluting beads

Mohamed I Al Sebayel, Prof.

Mohamed I Al Sebayel, Prof

Hamad AlSuhaibani, MD, FRCP

Faisal Aba AlKhail, MD

Ahmad M Al Zahrani, MD

Hussien A Elsiesy, MD

Hepatocellular Carcinoma (HCC) is a primary liver cancer. It is the 6th most common malignancy and the 3rd killers of all tumors worldwide with an incidence of 626,000 new patients a year. The intermediate stage of HCC is controlled by radiological interventions such as Transarterial Chemoembolization (TACE) or Radioembolization. Although 90Y radioembolization is increasingly being used in clinical practice, there is no high quality clinical evidence to justify this. To date, no prospective studies have been performed comparing both treatment modalities (TACE vs 90Y) in a randomized setting. This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC. This will be done by recruiting 75 patients in each arm from. Investigators will compare between the two groups the time to progression (TTP) as the primary outcome and also examine time to local progression (TLP) as well as other factors like overall survival, response to therapy, toxicities and adverse events, quality of life and treatment-related costs.

Study Rationale:

Although 90Y increasingly used in clinical practice, there is no high quality clinical evidence to justify this. Most of the comparison studies are retrospective. Three studies compared TACE with 90Y retrospectively. The first was by Kooby et al in which patients treated with TACE were retrospectively compared to those treated with 90Y suggested that both treatment modalities have similar effectiveness and safety profiles in patients with unresectable HCC. Earlier Carr et al carried out a similar retrospective analysis and concluded that Chemoembolization or Radioembolization appeared to be equivalent regional therapies for patients with unresectable, non-metastatic HCC. More recently Salem et al retrospectively compared 122 HCC patients who received chemo-embolization with 123 patients who received Radioembolization and concluded both patient groups had similar survival times. Radioembolization resulted in longer time-to-progression and less toxicity than chemo-embolization.

A study on down-staging of HCC beyond Milan criteria compare 90Y with TACE of and concluded that 90Y outperforms TACE for down-staging HCC to within transplant criteria.

TACE-DEB is the standardized form TACE with better efficacy and safety profile and will be ideal to use to define the position of 90Y in the of locoregional treatment of HCC.

To date, no prospective studies have been performed comparing both treatment modalities in a randomized setting. This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC.

Known Potential Benefits:

Chemo-embolization is the standard treatment for intermediate HCC with known efficacy and predicted toxicity. The arrival of TAC-DEBs made TACE more efficient, less toxic and more standardized. Y90 Radioembolization is of known efficacy and minimal toxicity base on cohort studies. Head to head comparison has never been conducted.

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma

King Faisal Specialist Hospital & Research Center

Chairman, Liver transplant department at KFSH&RC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma	NCT02729506	Hepatocellular ...	Transarterial R... Transarterial C...	18 Years - 80 Years	King Faisal Specialist Hospital & Research Center
Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma	NCT02729506	Hepatocellular ...	Transarterial R... Transarterial C...	18 Years - 80 Years	King Faisal Specialist Hospital & Research Center

Spots Global Cancer Trial Database for chemoembolization chemoembolization