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NCT07729618

AI-Guided First-Line Immunotherapy Selection in Unresectable Hepatocellular Carcinoma

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

This pragmatic, multicenter, cluster-randomized trial will evaluate whether a locked artificial intelligence (AI) clinical decision-support system can improve outcomes by helping multidisciplinary teams select first-line immune checkpoint inhibitor (ICI)-based systemic treatment for adults with unresectable hepatocellular carcinoma (HCC). Twenty-six hospitals or independent HCC multidisciplinary teams will be randomly assigned in a 1:1 ratio to AI-assisted treatment selection or usual-care treatment selection. Approximately 1,800 participants will be enrolled. Eligible participants must already be considered suitable for first-line ICI-based systemic therapy; the study does not compare immunotherapy with no immunotherapy. At AI-assisted sites, the system will use prespecified pretreatment information to estimate and compare expected outcomes across clinically appropriate, locally available, guideline-concordant ICI-based regimens. The AI output is advisory. Treating clinicians and patients retain responsibility for the final treatment decision, and reasons for not following an AI recommendation will be recorded. At usual-care sites, treatment will be selected through the standard multidisciplinary decision-making process without access to the AI output. Both groups will receive approved standard-of-care treatments. The AI model, input definitions, preprocessing pipeline, decision rules, thresholds, and software version will be locked before enrollment of the first participant and will not be retrained or modified using trial outcome data. Both groups will use the same eligibility criteria, patient-registration time point, imaging schedule, follow-up schedule, and outcome definitions. The primary outcome is progression-free survival assessed by blinded independent central imaging review. Overall survival is a key secondary outcome. Additional outcomes include tumor response, duration of response, safety, quality of life, treatment delivery, and implementation measures. This trial evaluates the clinical utility of a prespecified AI system rather than developing or optimizing another prediction model.

Official title: A Multicenter, Parallel-Group, Cluster-Randomized Controlled Trial Evaluating an Artificial Intelligence Clinical Decision Support System for Selection of First-Line Immune Checkpoint Inhibitor-Based Therapy in Unresectable Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1800

Start Date

2026-10-01

Completion Date

2029-12-01

Last Updated

2026-07-27

Healthy Volunteers

Conditions

Unresectable Hepatocellular Carcinoma

Interventions

OTHER

AI-Assisted Clinical Decision Support Strategy

A locked AI clinical decision-support system will analyze prespecified pretreatment information and provide the multidisciplinary team with patient-specific estimates and a comparative ranking of clinically appropriate first-line ICI-based treatment options. The recommendation is advisory and does not replace clinical judgment or shared decision-making.

OTHER

Usual-Care Multidisciplinary Treatment-Selection Strategy

First-line ICI-based treatment will be selected through the hospital's usual multidisciplinary decision-making process without access to the AI clinical decision-support system. Participants will otherwise undergo the same eligibility assessment, follow-up schedule, and outcome ascertainment as participants in the AI-assisted arm.

Inclusion Criteria: * Age 18 years or older. * Hepatocellular carcinoma confirmed by histology or cytology, or diagnosed using accepted noninvasive radiologic criteria. * Unresectable hepatocellular carcinoma for which first-line systemic therapy is indicated, including Barcelona Clinic Liver Cancer stage B disease that is unsuitable for or no longer benefiting from locoregional therapy, or stage C disease. * No prior systemic anticancer therapy for unresectable hepatocellular carcinoma. * Child-Pugh class A liver function. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Eligible and intended to receive at least one protocol-specified, guideline-concordant immune checkpoint inhibitor-based first-line regimen, as determined by the treating clinician before exposure to the study AI recommendation. * Eligibility confirmed and prospective participant registration completed before the final first-line treatment regimen is selected. * Baseline contrast-enhanced computed tomography or magnetic resonance imaging suitable for assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 is available before initiation of first-line systemic therapy. * Required pretreatment clinical data are available within the protocol-specified assessment windows. * Able to provide written informed consent. Exclusion Criteria: * Known combined hepatocellular-cholangiocarcinoma or another primary liver malignancy other than hepatocellular carcinoma. * A contraindication or clinical condition that makes all protocol-specified immune checkpoint inhibitor-based first-line regimens inappropriate according to applicable prescribing information and routine clinical practice. * Initiation of systemic therapy or completion of the final first-line regimen decision before prospective participant registration. * Exposure of the treating clinical team to the participant-specific AI recommendation before confirmation of eligibility and registration. * Concurrent anticancer treatment for another malignancy that would materially interfere with treatment selection or study outcome assessment. * Planned participation in another interventional study that dictates first-line systemic treatment or would interfere with study outcome assessment. * Inability to undergo protocol-required tumor imaging or follow-up assessments.

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China