Predictors of Sorafenib Response in HCC

NCT ID: NCT05967429

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-06-30

Brief Summary

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Evaluating the nutrition status of patients with advanced HCC who received sorafenib.

Using the pretreatment nutrition status and quality of life as predictors to sorafenib response

Detailed Description

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This a cross sectional study will be conducted on 100 HCC treated with sorafenib Data were gathered from medical records, including

age sex body weight and height (BMI) pre-therapy laboratory counts of white cells, neutrophils, lymphocytes, monocyte, hemoglobin and platelets; bilirubin, albumin and globulin concentration, AST, ALT, AFP, PT and CONC

Barcelona Clinic Liver Cancer Stage (BCLC) of all patients

The neutrophil-to- lymphocyte ratio (NLR) was calculated by dividing the neutrophil count by the lymphocyte count.

The platelet- to-lymphocyte ratio (PLR) was calculated by dividing the platelet count by the lymphocyte count.

Weight loss difference after treatment Portal hypertension was defined as presence of either collaterals on radiological examination, esophageal varices by upper gastrointestinal endoscopy and/or thrombocytopenia.

Quality of life assessment. QoL was assessed using FACT Hepatobiliary Symptom Index (FHSI-8) Questionnaire. QoL was assessed at base line and 3-6 months after start of treatment.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatocellular carcinoma receiving sorafenib

Patient with advanced stage HCC receiving sorafenib

The neutrophil-to- lymphocyte ratio

Intervention Type DIAGNOSTIC_TEST

It was calculated by dividing the neutrophil count by the lymphocyte count.

Prognostic nutrition index

Intervention Type DIAGNOSTIC_TEST

It was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/μL

Interventions

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The neutrophil-to- lymphocyte ratio

It was calculated by dividing the neutrophil count by the lymphocyte count.

Intervention Type DIAGNOSTIC_TEST

Prognostic nutrition index

It was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/μL

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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NLR PNI

Eligibility Criteria

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Inclusion Criteria

* HCC recieved sorafenib

Exclusion Criteria

* Patient refuse to participate
* Patients recieving other treatment modalities
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mona Mohammed Abdelrhman

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr Zagloul, MD

Role: STUDY_DIRECTOR

Sohag University

Ahmed othman, MD

Role: STUDY_CHAIR

Sohag University

Rafat Abd El Aal, MD

Role: STUDY_CHAIR

Sohag University

Central Contacts

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Mona Abdelrahmam, MD

Role: CONTACT

01021025895

References

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Takagi K, Buettner S, Ijzermans JNM. Prognostic significance of the controlling nutritional status (CONUT) score in patients with colorectal cancer: A systematic review and meta-analysis. Int J Surg. 2020 Jun;78:91-96. doi: 10.1016/j.ijsu.2020.04.046. Epub 2020 Apr 23.

Reference Type BACKGROUND
PMID: 32335238 (View on PubMed)

Other Identifiers

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Soh-Med-23-07-07PD

Identifier Type: -

Identifier Source: org_study_id

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