NCT04048317

Brief Summary

the aim of this work to compare effectiveness of drug-eluting bead trans-arterial chemo-embolization and conventional trans-arterial chemo-embolization of hepatic cell carcinoma in the aspect of (Tumor response via m-RECIST criteria), (liver injury via Liver function tests and tumor markers) and (survival outcome) of patients treated in Assiut university .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

July 26, 2019

Last Update Submit

August 6, 2019

Conditions

Hepatic Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effectiveness of drug-eluting bead trans-arterial chemo-embolization in patients of hepatocellular carcinoma

    Evaluate the efficacy and safety of drug-eluting bead trans-arterial chemo-embolization in management of HCC patients in comparison of conventional chemo-embolization in 75 stable patients by evaluating the response of embolized lesions for each drug with modified RECIST criteria.

    baseline

Study Arms (2)

drug eluting bead trans arterial chemo embolization

EXPERIMENTAL

the international arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Hepasphere

Drug: HepaSphere Microspheres/Doxorubicin Hydrochloride

conventional trans arterial chemo embolization

PLACEBO COMPARATOR

the control arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Lipiodol

Drug: Lipiodol

Interventions

HepaSphere Microspheres/Doxorubicin HydrochlorideDRUG

evaluation the tumor (size, location and pattern of enhancement) ;and ensure portal vein patency; then evaluation of hepatic arterial anatomy, after that we determine the tumor arterial feeders and the arteries that should be avoided during the maneuver. Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter then superselective angiogram were used microcatheter. then injection of drug-eluting microsphere (25 mg Hepasphere 50-100 micron) loaded with 50 mg doxorubicin solution for 2 hours.

drug eluting bead trans arterial chemo embolization
LipiodolDRUG

evaluation the tumor (size, location and pattern of enhancement) ;and ensure portal vein patency; then evaluation of hepatic arterial anatomy, after that we determine the tumor arterial feeders and the arteries that should be avoided during the maneuver. Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter then superselective angiogram were used microcatheter. then injection of prepared mixture of Lipiodol and (Doxorubicin or 5-FU) vary in dosage depend on operator consideration

conventional trans arterial chemo embolization

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients must be 18 to 75 years old.
  • patients must be diagnosed as primary Hepatocellular carcinoma (HCC) by radiologic imaging revealed angiogenicity pattern .
  • All of the patient have Child-Pugh status A or B .
  • All of the patient have BCLC stage A or B.
  • patients must have adequate renal and liver function accepting the maneuver.
  • patients must have adequate coagulation profile (platelets count ≥ 80 000), (prothrombin concentration ≥ 70 %).
  • patients must haven't previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation).

You may not qualify if:

  • patients have previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation).
  • patients with impaired coagulation profile (platelets count \< 80 000), (prothrombin concentration \< 70 %).
  • patients with decompensated liver cell failure having ascites which impedes the maneuver .
  • patients with past history of reaction to the drug used in maneuver
  • patients with poor image quality.
  • patients with lost follow up .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

    PMID: 25220842BACKGROUND

  • Kudo M, Izumi N, Kokudo N, Matsui O, Sakamoto M, Nakashima O, Kojiro M, Makuuchi M; HCC Expert Panel of Japan Society of Hepatology. Management of hepatocellular carcinoma in Japan: Consensus-Based Clinical Practice Guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version. Dig Dis. 2011;29(3):339-64. doi: 10.1159/000327577. Epub 2011 Aug 9.

    PMID: 21829027BACKGROUND

  • Zhang BH, Yang BH, Tang ZY. Randomized controlled trial of screening for hepatocellular carcinoma. J Cancer Res Clin Oncol. 2004 Jul;130(7):417-22. doi: 10.1007/s00432-004-0552-0.

    PMID: 15042359BACKGROUND

  • Yang HJ, Lee JH, Lee DH, Yu SJ, Kim YJ, Yoon JH, Kim HC, Lee JM, Chung JW, Yi NJ, Lee KW, Suh KS, Lee HS. Small single-nodule hepatocellular carcinoma: comparison of transarterial chemoembolization, radiofrequency ablation, and hepatic resection by using inverse probability weighting. Radiology. 2014 Jun;271(3):909-18. doi: 10.1148/radiol.13131760. Epub 2014 Feb 8.

    PMID: 24520944BACKGROUND

  • Salem R, Lewandowski RJ. Chemoembolization and radioembolization for hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2013 Jun;11(6):604-11; quiz e43-4. doi: 10.1016/j.cgh.2012.12.039. Epub 2013 Jan 26.

    PMID: 23357493BACKGROUND

  • Hsu CY, Huang YH, Chiou YY, Su CW, Lin HC, Lee RC, Chiang JH, Huo TI, Lee FY, Lee SD. Comparison of radiofrequency ablation and transarterial chemoembolization for hepatocellular carcinoma within the Milan criteria: a propensity score analysis. Liver Transpl. 2011 May;17(5):556-66. doi: 10.1002/lt.22273.

    PMID: 21506244BACKGROUND

  • Guo Z, Zhong Y, Hu B, Jiang JH, Li LQ, Xiang BD. Hepatic resection or transarterial chemoembolization for hepatocellular carcinoma within Milan criteria: A propensity score matching analysis. Medicine (Baltimore). 2017 Dec;96(51):e8933. doi: 10.1097/MD.0000000000008933.

    PMID: 29390426BACKGROUND

  • Dhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS. Prognostic factors for survival in patients with unresectable hepatocellular carcinoma undergoing chemoembolization with doxorubicin drug-eluting beads: a preliminary study. HPB (Oxford). 2010 Apr;12(3):174-80. doi: 10.1111/j.1477-2574.2009.00138.x.

    PMID: 20590884BACKGROUND

  • Lammer J, Malagari K, Vogl T, Pilleul F, Denys A, Watkinson A, Pitton M, Sergent G, Pfammatter T, Terraz S, Benhamou Y, Avajon Y, Gruenberger T, Pomoni M, Langenberger H, Schuchmann M, Dumortier J, Mueller C, Chevallier P, Lencioni R; PRECISION V Investigators. Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2010 Feb;33(1):41-52. doi: 10.1007/s00270-009-9711-7. Epub 2009 Nov 12.

    PMID: 19908093BACKGROUND

  • Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.

    PMID: 20175033BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

DoxorubicinEthiodized Oil

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesIodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Central Study Contacts

Ahmed M. Abdurabou, resident

CONTACT

00201149112036ahmedabdurabou@gmail.com

Haisam A. Atta, professor

CONTACT

00201005017866haisamasa@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident radiologist

Study Record Dates

First Submitted

July 26, 2019

First Posted

August 7, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

August 7, 2019

Record last verified: 2019-08