Hepatocellular CarcinomaPhase 4NCT02729506
Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma
A Phase 4 study testing Transarterial Radioembolization and Transarterial Chemoembolization using drug-eluting beads in people with Hepatocellular Carcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transarterial Radioembolization and Transarterial Chemoembolization using drug-eluting beads
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (see table)
- Patients must have adequate organ function as evidenced by:
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- Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥50 x 109/L Hg >9 g/d. AST or ALT ≤5 x ULN Serum creatinine ≤2 x ULN OR creatinine clearance ≥50 mL/min (estimated by Cockcroft Gault or measured) Normal mg and K Bleeding diathesis or on Vit. K therapy.
- Patients must fulfill Child-Pugh's Score
- Life expectancy equal to or more than 12 weeks.
- Signed informed consent.
- Sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after therapy.
- Female patients at child-bearing age must have negative pregnancy test.
- No known HIV infection.
Who cannot join
- Patients with metastases outside the liver.
- Patients with co-morbid condition that will be aggravated by the investigational drug or by the intervention.
- Patients with severe cardiopulmonary diseases (including history of stable, effort-induced or unstable angina pectoris or myocardiac infarction) and other systemic diseases under poor control.
- Patients with active infection.
- Patients with history of psychiatric disorder.
- Patients with concomitant active secondary malignancies, except for surgically cured carcinoma in situ of the cervix and basal or adequately treated squamous cell carcinoma of the skin. Disease-free of malignancies < 2 years before the study, are not eligible.
Show all 14Show fewer
- Clinically significant third space fluid accumulation (i.e., ascites requiring paracentesis despite use of diuretics) or pleural effusion that either requires thoracocentesis or is associated with shortness of breath
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection.
- Concurrent usage of hormonal or chemotherapeutic agents.
- Patients who received surgery, radiotherapy except to bone, chemotherapy, immunotherapy, or other investigational drug within 4 weeks before initiating study are not eligible.
- Patients who are pregnant, breast-feeding or not using appropriate birth control during the course of the study.
- Patients with partner of child bearing age who are not willing to use appropriate contraceptives during and 8 week after therapy.
- Non compliance.
- Unwilling to disclose medical information.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal Specilist Hopsital & Researchc Center
Riyadh, 11211
Mohamed I Al Sebayel, Prof, msebayel@kfshrc.edu.sa
Hamad AlSuhaibani, MD, FRCP
About this study
Official title: Transarterial Radioembolization Versus Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma
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.
Read the detailed description
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transarterial Radioembolization, Transarterial Chemoembolization using drug-eluting beads
- Keywords
- hepatocellular carcinoma, transarterial radioembolization, chemoembolization chemoembolization, clinical trial
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial RadioembolizationProcedure or surgery
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 Chemoembolization using drug-eluting beadsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | 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 Receives: Procedure: Transarterial Radioembolization |
| Arm B | Active comparator | 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 Receives: Procedure: Transarterial Chemoembolization using drug-eluting beads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (TTP) is the primary outcome.
Measured: 12 month
Secondary outcomes (6)
Time to Local Progression (TLP)
Measured: 12 month
Overall survival
Measured: 12 month
Overall response to therapy according to mRECIST
Measured: 12 month
Toxicities and adverse events
Measured: 12 month
Quality of life
Measured: 12 month
Treatment-related costs, in terms of cost of therapy and number of hospitalization days.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Alsebayel, King Faisal Specialist Hospital & Research Center
- Investigators
- Mohamed I Al Sebayel, Prof, Principal investigator, King Faisal Specilaist Hopsital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729506
- Sponsor's protocol ID
- RAC# 2131 134
- Status last verified
- Mar 2016
- First submitted
- 4 Feb 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
PubMed 15761078El-Serag HB. Hepatocellular carcinoma: recent trends in the United States. Gastroenterology. 2004 Nov;127(5 Suppl 1):S27-34. doi: 10.1053/j.gastro.2004.09.013.
PubMed 15508094Liapi E, Geschwind JF. Transcatheter and ablative therapeutic approaches for solid malignancies. J Clin Oncol. 2007 Mar 10;25(8):978-86. doi: 10.1200/JCO.2006.09.8657.
PubMed 17350947Llovet JM, Fuster J, Bruix J; Barcelona-Clinic Liver Cancer Group. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma. Liver Transpl. 2004 Feb;10(2 Suppl 1):S115-20. doi: 10.1002/lt.20034.
PubMed 14762851Bruix J, Llovet JM. Major achievements in hepatocellular carcinoma. Lancet. 2009 Feb 21;373(9664):614-6. doi: 10.1016/S0140-6736(09)60381-0. No abstract available.
PubMed 19231618BREEDIS C, YOUNG G. The blood supply of neoplasms in the liver. Am J Pathol. 1954 Sep-Oct;30(5):969-77. No abstract available.
PubMed 13197542Liapi E, Georgiades CC, Hong K, Geschwind JF. Transcatheter arterial chemoembolization: current technique and future promise. Tech Vasc Interv Radiol. 2007 Mar;10(1):2-11. doi: 10.1053/j.tvir.2007.08.008.
PubMed 17980314Buijs M, Vossen JA, Frangakis C, Hong K, Georgiades CS, Chen Y, Liapi E, Geschwind JF. Nonresectable hepatocellular carcinoma: long-term toxicity in patients treated with transarterial chemoembolization--single-center experience. Radiology. 2008 Oct;249(1):346-54. doi: 10.1148/radiol.2483071902.
PubMed 18796686Lewandowski RJ, Kulik LM, Riaz A, Senthilnathan S, Mulcahy MF, Ryu RK, Ibrahim SM, Sato KT, Baker T, Miller FH, Omary R, Abecassis M, Salem R. A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization. Am J Transplant. 2009 Aug;9(8):1920-8. doi: 10.1111/j.1600-6143.2009.02695.x. Epub 2009 Jun 22.
PubMed 19552767Lewandowski RJ, Mulcahy MF, Kulik LM, Riaz A, Ryu RK, Baker TB, Ibrahim SM, Abecassis MI, Miller FH, Sato KT, Senthilnathan S, Resnick SA, Wang E, Gupta R, Chen R, Newman SB, Chrisman HB, Nemcek AA Jr, Vogelzang RL, Omary RA, Benson AB 3rd, Salem R. Chemoembolization for hepatocellular carcinoma: comprehensive imaging and survival analysis in a 172-patient cohort. Radiology. 2010 Jun;255(3):955-65. doi: 10.1148/radiol.10091473.
PubMed 20501733Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.
PubMed 12049862Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156.
PubMed 11981766Camma C, Schepis F, Orlando A, Albanese M, Shahied L, Trevisani F, Andreone P, Craxi A, Cottone M. Transarterial chemoembolization for unresectable hepatocellular carcinoma: meta-analysis of randomized controlled trials. Radiology. 2002 Jul;224(1):47-54. doi: 10.1148/radiol.2241011262.
PubMed 12091661Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.
PubMed 12540794Oliveri RS, Wetterslev J, Gluud C. Transarterial (chemo)embolisation for unresectable hepatocellular carcinoma. Cochrane Database Syst Rev. 2011 Mar 16;2011(3):CD004787. doi: 10.1002/14651858.CD004787.pub2.
PubMed 21412886
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Radioembolization Versus Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02729506
- Acronym / sponsor ID
- RAC# 2131 134
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, transarterial radioembolization, chemoembolization chemoembolization, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: Transarterial RadioembolizationIntervention: 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 |
| Arm B | Active comparator | Procedure: Transarterial Chemoembolization using drug-eluting beadsIntervention: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 (see table)
Key exclusion criteria (14 listed)
- Patients with metastases outside the liver.
- Patients with co-morbid condition that will be aggravated by the investigational drug or by the intervention.
- Patients with severe cardiopulmonary diseases (including history of stable, effort-induced or unstable angina pectoris or myocardiac infarction) and other systemic diseases under poor control.
- Patients with active infection.
- Patients with history of psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial RadioembolizationYttrium-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. | Procedure or surgery | Arm A |
| Transarterial Chemoembolization using drug-eluting beadsTACE 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. | Procedure or surgery | Arm B |
Primary outcome
Time to Progression (TTP) is the primary outcome.
Time frame: 12 month
6 secondary outcomes
Time to Local Progression (TLP)
Time frame: 12 month
Overall survival
Time frame: 12 month
Overall response to therapy according to mRECIST
Time frame: 12 month
Toxicities and adverse events
Time frame: 12 month
Quality of life
Time frame: 12 month
Treatment-related costs, in terms of cost of therapy and number of hospitalization days.
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Results publication: PubMed 15761078Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
- Results publication: PubMed 15508094El-Serag HB. Hepatocellular carcinoma: recent trends in the United States. Gastroenterology. 2004 Nov;127(5 Suppl 1):S27-34. doi: 10.1053/j.gastro.2004.09.013.
- Results publication: PubMed 17350947Liapi E, Geschwind JF. Transcatheter and ablative therapeutic approaches for solid malignancies. J Clin Oncol. 2007 Mar 10;25(8):978-86. doi: 10.1200/JCO.2006.09.8657.
- Results publication: PubMed 14762851Llovet JM, Fuster J, Bruix J; Barcelona-Clinic Liver Cancer Group. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma. Liver Transpl. 2004 Feb;10(2 Suppl 1):S115-20. doi: 10.1002/lt.20034.
- Results publication: PubMed 19231618Bruix J, Llovet JM. Major achievements in hepatocellular carcinoma. Lancet. 2009 Feb 21;373(9664):614-6. doi: 10.1016/S0140-6736(09)60381-0. No abstract available.
- Results publication: PubMed 13197542BREEDIS C, YOUNG G. The blood supply of neoplasms in the liver. Am J Pathol. 1954 Sep-Oct;30(5):969-77. No abstract available.
- Results publication: PubMed 17980314Liapi E, Georgiades CC, Hong K, Geschwind JF. Transcatheter arterial chemoembolization: current technique and future promise. Tech Vasc Interv Radiol. 2007 Mar;10(1):2-11. doi: 10.1053/j.tvir.2007.08.008.
- Results publication: PubMed 18796686Buijs M, Vossen JA, Frangakis C, Hong K, Georgiades CS, Chen Y, Liapi E, Geschwind JF. Nonresectable hepatocellular carcinoma: long-term toxicity in patients treated with transarterial chemoembolization--single-center experience. Radiology. 2008 Oct;249(1):346-54. doi: 10.1148/radiol.2483071902.
- Results publication: PubMed 19552767Lewandowski RJ, Kulik LM, Riaz A, Senthilnathan S, Mulcahy MF, Ryu RK, Ibrahim SM, Sato KT, Baker T, Miller FH, Omary R, Abecassis M, Salem R. A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization. Am J Transplant. 2009 Aug;9(8):1920-8. doi: 10.1111/j.1600-6143.2009.02695.x. Epub 2009 Jun 22.
- Results publication: PubMed 20501733Lewandowski RJ, Mulcahy MF, Kulik LM, Riaz A, Ryu RK, Baker TB, Ibrahim SM, Abecassis MI, Miller FH, Sato KT, Senthilnathan S, Resnick SA, Wang E, Gupta R, Chen R, Newman SB, Chrisman HB, Nemcek AA Jr, Vogelzang RL, Omary RA, Benson AB 3rd, Salem R. Chemoembolization for hepatocellular carcinoma: comprehensive imaging and survival analysis in a 172-patient cohort. Radiology. 2010 Jun;255(3):955-65. doi: 10.1148/radiol.10091473.
- Results publication: PubMed 12049862Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.
- Results publication: PubMed 11981766Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed I Al Sebayel, Prof principal investigator
King Faisal Specilaist Hopsital & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transarterial Radioembolization and Transarterial Chemoembolization using drug-eluting beads in people with Hepatocellular Carcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed I Al Sebayel, Prof. (+966114647272 ext. 24818, msebayel@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Progression (TTP) is the primary outcome. (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729506, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.