Intelligence System for Predicting Atezolizumab-Bevacizumab Response and Clinical Outcomes in Unresectable Hepatocellular Carcinoma

NCT07495735 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-394
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter retrospective clinical research, led by the First Affiliated Hospital of Wenzhou Medical University, and jointly conducted by other sub-centers. The aim is to develop an non-invasive artificial intelligence system for predicting the response and clinical outcomes of patients with unresectable hepatocellular carcinoma (uHCC) to the treatment with atezolizumab combined with bevacizumab (T+A). In response to the clinical situation where approximately half of uHCC patients do not respond to the standard T+A therapy and traditional invasive biopsy is unable to fully reflect the heterogeneity of the tumor microenvironment, this study plans to retrospectively collect the data of 400 patients who met the inclusion and exclusion criteria from January 2020 to November 2025. The study will systematically summarize multi-dimensional data such as enhanced CT images within one month before treatment, baseline characteristics, serum markers, liver disease factors, and tumor stage. By integrating these clinical features with deep learning imageomics features extracted from images, the research team is dedicated to constructing and validating a safe, non-invasive, and reproducible prediction model, with the aim of achieving precise identification of the benefit population before implementing immunotherapy combined with anti-angiogenic treatment, and providing a powerful intelligent tool support for optimizing clinical treatment decisions and improving patient survival prognosis.

Conditions

HCC - Hepatocellular Carcinoma; Atezolizumab and Bevacizumab in Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  through study completion, an average of 1 year

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

unresectable HCC patients

You may qualify if:

• (i) Clinical or pathological diagnosis of HCC;
• (ii) Administration of atezolizumab-bevacizumab treatment;
• (iii) At least 18 years old.

You may not qualify if:

• (i) Lack of key clinical data (laboratory test results), or lack of enhanced CT images taken within one month before treatment;
• (ii) Comorbid with other malignant tumors;
• (iii) PS score \> 2 or Child-Pugh score \> 7;
• (iv) Unable to evaluate tumor response;
• (v) Loss to follow-up.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Observation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatobiliary Surgery, Clinical Professor, Vice President

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: March 22, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03