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

N/AActive Not RecruitingNCT07581769

First Affiliated Hospital, Sun Yat-Sen University500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Hepatocellular Carcinoma (HCC)Downstaging Liver Resection Lenvatinib

Interventions

Liver resectionPROCEDURE

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.

TACE plus Lenvatinib and PD1 inhibiterPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria; 2. 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; 3. 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; 4. Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment; 5. Performance status (PS) score of 0 or 1. Exclusion Criteria: 1. Patients with unclear diagnoses or those with concurrent other malignancies. 2. For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively. 3. For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors. 4. Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy. 5. Patients with severe infections, such as respiratory, biliary tract, or abdominal infections. 6. Patients with severe underlying diseases, particularly immune-related disorders.

Outcomes

Primary Outcomes

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

Time frame: 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

Overall survival

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

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