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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06313047
Other study ID # Doxorubacin in HCC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 30, 2023

Study information

Verified date March 2024
Source Damanhour University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study included 81 HCC patients, both male and female. Prior to being assessed for eligibility, each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results. Every research participant take part in the experiment and provided written informed consent.


Description:

All patients had their baseline viral indicators for HBV and HCV evaluated. Additionally, blood samples were taken for genotyping. All patients underwent evaluations of their kidney, liver, and alpha fetoprotein (AFP) functions, as well as their complete blood count (CBC), at both the baseline and follow-up appointments. To evaluate the efficacy of TACE, triple pelvic abdominal CT scans were performed both prior to and one month later. Using triphasic pelviabdominal CT, patients who achieved complete response (CR) were monitored for up to 13 months following chemotherapy in order to identify recurrence. Follow-up appointments were planned to identify patients responces or any negative effects.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date December 30, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: 1. When diagnosing the patient with HCC, the guidelines provided by the American Association for the Study of Liver Diseases (AASLD) were adhered to. 2. Be above 20 years old. 3. Individuals with intact organs. 4. There is no cure for HCC in surgery, microwave treatment, or radiofrequency ablation. Exclusion Criteria: 1. The patients refused to sign the formal consent. 2. Be more than 75 years old. 3. There is a notable case of portal vein thrombosis. 4. Spreads beyond the liver. 5. Encephalopathy of the liver. 6. Present sickness.

Study Design


Intervention

Drug:
Doxorubicin
each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results.

Locations

Country Name City State
Saudi Arabia King Abdullah bin Abdulaziz University Hospital Riyadh

Sponsors (3)

Lead Sponsor Collaborator
Rehab Werida King Abdullah Bin Abdulaziz University Hospital, King Saud Bin Abdulaziz University for Health Sciences

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary GSTP1 Genotyping 1 year
Primary CYP2B6 Genotyping 1 year
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