Radiomics Subtyping to Guide Surgery vs. Maintenance Therapy After HCC Downstaging
A Retrospective Radiomics-Based Subtyping Study to Guide Post-Downstaging Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma Following TACE Plus Lenvatinib and Anti PD-1
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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 510280
- ZhuJiang Hospital of Southern Medical University
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Guangzhou, Guangdong, 중국, 510080
- The First Affiiated Hospital of Sun Yat-sen University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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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.
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Recurrence free survival
기간: 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
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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
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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전체 생존율
기간: 초기 치료 시작일부터 모든 원인에 의한 사망일까지 중 먼저 도래한 시점까지 평가하며, 최대 24개월 동안 평가됨
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초기 치료 시작일부터 어떤 원인으로든 사망한 날까지의 시간 간격(먼저 발생한 날짜 기준)으로, 최대 24개월까지 평가됨
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초기 치료 시작일부터 모든 원인에 의한 사망일까지 중 먼저 도래한 시점까지 평가하며, 최대 24개월 동안 평가됨
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wenzhe Fan, Dr., First Affiliated Hospital, Sun Yat-Sen University
- 수석 연구원: Shunjun Fu, Dr., Southern Medical University, China
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-KY-180-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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