Strategy Option in Combined locoregional treatment (Strategy CHemoEMbolization & Ablation) of patients with hepatocellular carcinoma: A Non-inferiority Randomized Multicenter Trial

Phase 1

• Conditions: ninodular or multinodular (maximum 3 nodules) HCC with target lesion(s) = 3 cm and < 7 cm in size, not suitable for surgery, with unilobar Disease, with liver cirrhosis classified as Child-Pugh score till B7; MedDRA version: 21.1Level: PTClassification code 10062040Term: Liver operationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003094-21-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients older than 18 years of age
• Uninodular or multinodular (maximum 3 nodules) HCC with target lesion(s) = 3 cm and < 7 cm in size, not suitable for surgery
• Unilobar Disease
• Adequate information and subsequent written informed consent
• Tumor volume = 50% of liver volume
• Liver cirrhosis classified as Child-Pugh score A or B7
• normalized ratio (INR) < 1.5; if a patient was on anticoagulants, they had to be able to stop medication temporarily prior to transarterial chemoembolization and have INR < 1.5 at the time of the procedure
• Adequate liver function, defined by total bilirubin < 2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase was more than five times upper limit of normal range, and albumin > 2.5 g/dl
• Adequate renal function, defined by serum creatinine < 2.0 mg/dl
• No confirmed extrahepatic metastases, except for limited extra-hepatic spread defined as portal or mesenteric lymph nodes at imaging up to 2.5 cm each based on measurement of the short axis, focal lung lesion single < 1.5 cm or multiple lesions for a total diameter < 2 cm
• Performance status (ECOG) classified as 0-1 category
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96

Exclusion Criteria

• Known hypersensitivity reactions towards components of the study drugs
• Child-Pugh score > B7
• Performance status (ECOG) = 2,
• Macrovascular invasion, only if assessed on pre-procedural imaging
• Platelet count < 40,000/µL and/or international normalized ratio >1.5,
• Severe renal impairment or serum creatinine levels = 2 mg/dl
• Family, psychological, social or geographical circumstances preventing the patients from undergoing follow-up and from complying with protocol procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified