Heterogeneity of Treatment Effects of Adding Locoregional Therapies to Atezolizumab Plus Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma (ISMIO-026)
Heterogeneity of Treatment Effects of Adding Locoregional Therapies to Atezolizumab Plus Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma Based on Clinical and Multiregional, Multiphase Contrast-Enhanced CT/MRI Features (ISMIO-026)
uHCC imposes a substantial disease burden in China and the Asia-Pacific region. Atezo+Bev is an important first-line regimen for patients who have not received prior systemic therapy; however, not all patients achieve adequate and durable tumor control. In clinical practice, ablation, radiotherapy, or transarterial therapy is often added to Atezo+Bev to intensify intrahepatic disease control. The indications, timing, efficacy, and risk of liver-function impairment vary across LRTs. Most existing studies report average treatment effects and often use TACE as a fixed backbone, and therefore do not directly identify which patients receiving Atezo+Bev should receive early LRTs.
Using target trial emulation and HTE analysis, this study will integrate baseline clinical variables with pretreatment contrast-enhanced CT/MRI features to estimate the CATE of early LRT initiation and identify patients likely to achieve greater survival benefit.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jian Lu
- 전화번호: 13616106021
- 이메일: lujian43307131@126.com
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국, 213003
- Zhongda hospital
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연락하다:
- Jun-Hao Mei
- 전화번호: 15052007938
- 이메일: jh_mei240225@126.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥18 years on the index date.
- Receipt of at least one dose each of atezolizumab and bevacizumab as part of the same first-line combination regimen, with an interval of ≤28 days between the first administrations of the two drugs.
- At least one intrahepatic lesion amenable to a protocol-specified LRT on the index date, with no absolute contraindication to Atezo+Bev or to all feasible LRTs.
- A clinical, radiologic, or pathologic diagnosis of uHCC on or before the index date; baseline EHS is permitted.
- Survival status or the date last known alive after the index date can be ascertained.
- No systemic therapy for HCC before the regimen initiation date.
- No LRT within 60 days before the index date or between baseline imaging and the index date; earlier prior LRTs are permitted provided that an untreated, measurable intrahepatic lesion remains.
- A technically adequate baseline contrast-enhanced CT/MRI examination and at least one untreated intrahepatic lesion that can be delineated and evaluated.
- Baseline ECOG performance status of 0-2.
Exclusion Criteria:
- Another primary malignancy requiring active systemic treatment on the index date, except for a malignancy that has been cured and has a low risk of recurrence.
- Participation on the index date in an interventional study that could affect treatment allocation or outcome assessment.
- Suitability for immediate curative resection or liver transplantation following multidisciplinary assessment.
- An absolute contraindication to Atezo+Bev or to all feasible LRTs.
- Active autoimmune disease or immunodeficiency requiring systemic immunosuppression or constituting a contraindication to atezolizumab.
Inadequately controlled high-risk esophageal/gastric varices, recent variceal bleeding, an uncorrected bleeding tendency, or clinically significant coagulopathy.
- Inability to determine the index date, primary treatment strategy, OS outcome/censoring date, or absence of a technically adequate baseline contrast-enhanced CT/MRI examination.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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훈련 코호트
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Retrospective validation cohort
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Prospective validation cohort
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Biological validation cohort
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall survival
기간: through study completion, an average of 1 year
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With OS as the primary outcome, to estimate the overall treatment effect and CATE of initiating LRTs within 60 days after Atezo+Bev initiation versus not initiating LRTs within 60 days; and to integrate baseline clinical variables with multiregional radiomic, dynamic/habitat, and deep representation features from pretreatment contrast-enhanced CT/MRI to develop and validate an HTE decision model.
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through study completion, an average of 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Model calibration
기간: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Benefit ranking
기간: through study completion, an average of 1 year
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through study completion, an average of 1 year
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PFS/mPFS
기간: through study completion, an average of 1 year
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Defined as the time from index date to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 or mRECIST.
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through study completion, an average of 1 year
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adverse event
기간: through study completion, an average of 1 year
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To describe and compare the spectrum and severity of AEs between the two strategies and within their subgroups, with particular attention to hemorrhage, hypertension, hepatotoxicity, immune-related AEs, and complications associated with each type of LRT.
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through study completion, an average of 1 year
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
기타 연구 ID 번호
- ISMIO-026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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