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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003094-21-IT

Enrollment

160

Registered

2021-05-24

Start date

2021-02-11

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uninodular 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: 21.1 Level: PT Classification code 10062040 Term: Liver operation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: adriblastina Product Name: Doxorubicin Product Code: [Doxorubicin] Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: Doxorubicin CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients older than 18 years of age • Uninodular or multinodular (maximum 3 nodules) HCC with target lesion(s) = 3 cm and 2.5 g/dl • Adequate renal function, defined by serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 96

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to compare the two combined options in terms of complete response of a target lesion obtained at MRI follow-up (performed after 4 weeks and within 3 months post-treatment) for the treatment of unresectable early-intermediate HCC patients, with maximum 3 nodules, with the target lesion greater than 3 cm and less than 7 cm in size.;Secondary Objective: Secondary objectives: The two combined treatments will be also compared in terms of: -Feasibility, defined as the proportion of “technical success”; -Safety Profile (periprocedural complications and overall adverse events); -Fluoroscopy Time and Procedural Duration -Overall Response (OR) and Overall Disease Control (ODC) at 1- 3- and 6-month follow-up; -Progression-Free-Survival (PFS); -Overall Survival (OS); -QoL with a questionnaire (assessed before and after the treatment – day 1 and day 30).;Primary end point(s): Primary Endopoint: Early Complete Response Rate (within 3 months);Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: The main objective of the study is to compare the two combined options in terms of complete response of a target lesion obtained at MRI follow-up (performed after 4 weeks and within 3 months post-treatment) for the treatment of unresectable early-intermediate HCC patients, with maximum 3 nodules, with the target lesion greater than 3 cm and less than 7 cm in size.;Secondary Objective: Secondary objectives: The two combined treatments will be also compared in terms of: -Feasibility, defined as the proportion of “technical success”; -Safety Profile (periprocedural complications and overall adverse events); -Fluoroscopy Time and Procedural Duration -Overall Response (OR) and Overall Disease Control (ODC) at 1- 3- and 6-month follow-up; -Progression-Free-Survival (PFS); -Overall Survival (OS); -QoL with a questionnaire (assessed before and after the treatment – day 1 and day 30).;Primary end point(s): Primary Endopoint: Early Complete Response Rate (within 3 months);Timepoint(s) of evaluation of this end point: 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): END POINT SECONDARI: - PFS (progression free survival) - OS: overall survival 1 year - ORR (overall response rate) - ODC (Overall disease control);Timepoint(s) of evaluation of this end point: LVLS	—

Countries

Germany, Italy, Spain

Contacts

Public ContactDirezione Scientifica

Fondazione Policlinico Universitario A. Gemelli IRCCS

DIREZIONE.SCIENTIFICA@POLICLINICOGEMELLI.IT0630155701

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026