deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT03007225

Efficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients

Sponsor: Ain Shams University

Updated 10 times since 2017 Last updated: Sep 27, 2020 Started: Jul 31, 2015 Primary completion: Aug 31, 2016 Completion: Aug 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on HepatoCellular Carcinoma, this trial is completed. The trial is conducted by Ain Shams University and has accumulated 10 data snapshots since 2015. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

This prospective case control was conducted at the Department of Tropical Medicine and HCC Clinic, Ain Shams University Hospitals (Cairo, Egypt), The patients were divided according to the line of treatment into 2 groups: 1. Group (I): Twenty-five patients underwent Chemoembolization with Drug eluting beads. 2. Group (II): Twenty-five patients underwent conventional Chemoembolization (cTACE) The total number of procedures was 77 sessions (37 sessions of TACE with beads and 40 sessions of conventional TACE).Post-procedure follow up: Schedule of follow up: All included patients were checked at: 1. One week after the procedure to detect early post chemoembolization complications and Patients were subjected to Liver function tests, Kidney function tests, complete blood count and Abdominal Ultrasound. 2. One and four months after the maneuver. Patients were subjected to the following in each visit: 1. Complete History taking 2. Thorough clinical examination 3. Laboratory Investigations including: 1. Liver function tests 2. Kidney function tests 3. CBC 4. Serum alpha-fetoprotein. 4. Triphasic pelvi-abdominal CT Follow up imaging was performed at the first and fourth months after embolization and every 3 months thereafter. Repeated embolization was scheduled "on demand" basis, if there was residual viable tumor deemed unsuitable for radiofrequency ablation or surgery.

This prospective case control was conducted at the Department of Tropical Medicine and HCC Clinic, Ain Shams University Hospitals (Cairo, Egypt), The patients were divided according to the line of treatment into 2 groups:

1. Group (I): Twenty-five patients underwent Chemoembolization with Drug eluting beads. 2. Group (II): Twenty-five patients underwent conventional Chemoembolization (cTACE)

The total number of procedures was 77 sessions (37 sessions of TACE with beads and 40 sessions of conventional TACE).Post-procedure follow up:

Schedule of follow up:

All included patients were checked at:

1. One week after the procedure to detect early post chemoembolization complications and Patients were subjected to Liver function tests, Kidney function tests, complete blood count and Abdominal Ultrasound. 2. One and four months after the maneuver.

Patients were subjected to the following in each visit:

1. Complete History taking 2. Thorough clinical examination 3. Laboratory Investigations including:

1. Liver function tests 2. Kidney function tests 3. CBC 4. Serum alpha-fetoprotein. 4. Triphasic pelvi-abdominal CT Follow up imaging was performed at the first and fourth months after embolization and every 3 months thereafter. Repeated embolization was scheduled "on demand" basis, if there was residual viable tumor deemed unsuitable for radiofrequency ablation or surgery.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Oct 2020 · 28 months · monthly snapshotCompleted~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshotCompleted~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Present [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE4

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE4

Show 5 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE4

  2. Nov 2020 — Jan 2021 [monthly]

    Completed PHASE4

  3. Oct 2020 — Nov 2020 [monthly]

    Completed PHASE4

  4. Jun 2018 — Oct 2020 [monthly]

    Completed PHASE4

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Jul 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ain Shams University
Data source: Ain Shams University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.