Radiomics Subtyping to Guide Surgery vs. Maintenance Therapy After HCC Downstaging

NCT07581769 | Active Not Recruiting DMC

• 1 other identifier: 2026-KY-180-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to learn about the long-term treatment outcomes for patients with initially unresectable hepatocellular carcinoma (HCC) who achieve successful downstaging with the combination therapy of TACE, lenvatinib, and a PD-1 inhibitor. The main questions it aims to answer are: Can distinct disease subtypes be identified in successfully downstaged patients using radiomics and clinical data? Do these different subtypes show significant differences in long-term outcomes, such as recurrence-free survival and overall survival, after undergoing either curative-intent surgical resection or continuing maintenance therapy? Based on the identified subtypes, can the investigators objectively determine which patients are more suitable for surgical resection and which patients may benefit more from continued maintenance therapy after successful downstaging? The study will include patients who have already undergone the combination therapy as part of their regular medical care, successfully achieved tumor downstaging (making the tumor technically resectable), and subsequently received either surgical resection or continued maintenance treatment. Researchers will retrospectively analyze their existing clinical and imaging data to compare long-term outcomes between these two treatment paths based on their identified disease subtype.

Conditions

Downstaging; Liver Resection; PD1 Antibody; Transarterial Chemoembolization; Hepatocellular Carcinoma (HCC); Lenvatinib

Keywords

Downstaging; Hepatocellular carcinoma; Liver resection; Lenvatinib; PD1 antibody; Transarterial chemoembolization

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

  Time interval from date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months

  From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (1)

• Overall survival

  From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (2)

Maintenance group

This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after successful downstaging achieved through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, continued with the same non-surgical, maintenance treatment regimen instead of undergoing surgical resection.

Procedure: TACE plus Lenvatinib and PD1 inhibiter

Liver Resection group

This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after achieving successful downstaging through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, underwent curative-intent surgical resection (R0 resection) as their subsequent treatment.

Procedure: Liver resection

Interventions

Liver resection PROCEDURE

This intervention consists of curative-intent surgical resection of hepatocellular carcinoma (HCC) performed after successful downstaging achieved through prior TACE combined with lenvatinib and PD-1 inhibitor therapy. The procedure aims to remove all visible and radiologically responsive tumor tissue to achieve a pathologically confirmed R0 resection margin.

Liver Resection group

TACE plus Lenvatinib and PD1 inhibiter PROCEDURE

This intervention describes the non-surgical maintenance therapy for patients in the Maintenance Group after successful downstaging. It consists of continuing the same doses of lenvatinib and PD-1 inhibitor that were administered during the downstaging phase, combined with on-demand TACE performed only upon imaging or biomarker evidence of intrahepatic progression.

Maintenance group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with initially unresectable hepatocellular carcinoma who were treated with a combination therapy of TACE, lenvatinib, and a PD-1 inhibitor and subsequently achieved successful tumor downstaging.

You may qualify if:

• Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
• Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation; Underwent treatment with TACE combined with lenvatinib and a PD-1 inhibitor, after which the tumor was re-evaluated and deemed resectable by surgical assessment;
• Following the achievement of surgical resectability criteria, patients subsequently underwent either R0 surgical resection or continued treatment with TACE combined with lenvatinib and a PD-1 inhibitor;
• Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
• Performance status (PS) score of 0 or 1.

You may not qualify if:

• Patients with unclear diagnoses or those with concurrent other malignancies.
• For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively.
• For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors.
• Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy.
• Patients with severe infections, such as respiratory, biliary tract, or abdominal infections.
• Patients with severe underlying diseases, particularly immune-related disorders.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead
• Zhujiang Hospital: collaborator

Study Sites (2)

The First Affiiated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy; lenvatinib

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)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Wenzhe Fan, Dr.

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Shunjun Fu, Dr.

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)