TARE로 치료가 가능한 절제 불가능한 간세포암종 환자를 대상으로 Durvalumab 및 Bevacizumab 치료와 병용하여 경동맥 방사선색전술(TARE)을 평가하기 위한 미국 연구 (EMERALD-Y90)
국소 부위 치료가 가능한 절제 불가능한 간세포암종에서 Yttrium-90 유리 미소구체(TheraSphere™)를 사용한 경동맥 방사선색전술 후 Durvalumab 및 Bevacizumab에 대한 제2상 단일군 연구
The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.
연구 개요
상태
정황
상세 설명
A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant.
Participants with previous Transarterial Chemoembolization (TACE) or TARE associated with the curative setting are permitted with a 6-month washout.
Approximately 120 participants with unresectable but amenable to locoregional therapy HCC eligible for embolization will be screened in the study at approximately 20 sites in the US to enroll approximately 60 participants.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045
- Research Site
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Florida
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Gainesville, Florida, 미국, 32608
- Research Site
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Orlando, Florida, 미국, 32804
- Research Site
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Georgia
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Atlanta, Georgia, 미국, 30322
- Research Site
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Atlanta, Georgia, 미국, 30342
- Research Site
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Illinois
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Chicago, Illinois, 미국, 60611
- Research Site
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- Research Site
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Michigan
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Detroit, Michigan, 미국, 48201
- Research Site
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Missouri
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St Louis, Missouri, 미국, 63110
- Research Site
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New Jersey
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Trenton, New Jersey, 미국, 08690
- Research Site
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New York
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Buffalo, New York, 미국, 14263
- Research Site
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New York, New York, 미국, 10029
- Research Site
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- Research Site
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Ohio
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Columbus, Ohio, 미국, 43210
- Research Site
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Oregon
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Portland, Oregon, 미국, 97239
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Research Site
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Texas
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Houston, Texas, 미국, 77030
- Research Site
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Virginia
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Charlottesville, Virginia, 미국, 22908
- Research Site
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Washington
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Seattle, Washington, 미국, 98195
- Research Site
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Research Site
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Milwaukee, Wisconsin, 미국, 53215
- Research Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants with confirmed unresectable HCC
- Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume.
- Participants with more than 1 prior embolization are permitted if more than 12 months ago, for a different primary lesion, and FLR > 30%.
- Participants with no evidence of extrahepatic disease on any available imaging
- Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
- Participants having Child-Pugh score class A.
- Participants having ECOG performance status of 0 or 1 at enrollment
- Adequate organ and marrow function
Exclusion Criteria:
- Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant.
- Participants co-infected with HBV and HDV
- Any history of nephrotic or nephritic syndrome.
- Clinically significant (eg, active) cardiovascular disease
- Participants with uncontrolled hypertension
- History of hepatic encephalopathy
- Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
- Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
- Participant has received any prior anticancer systemic therapy for unresectable HCC.
- History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
- History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Yttrium 90 glass microspheres TARE in combination with Durvalumab and Bevacizumab
Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation. |
Durvalumab IV (intravenous)
다른 이름들:
Bevacizumab IV (intravenous)
다른 이름들:
Yttrium 90 glass microspheres will be administered
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression Free Survival (PFS)
기간: From Day 1 until date of progressive disease or death [Approximately 3 years]
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PFS is defined as the time from Day 1 (day of TARE) until the date of progressive disease per modified Response Evaluation Criteria in Solid Tumors (mRECIST), as assessed by the investigator, or death due to any cause. It is measured to assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy. |
From Day 1 until date of progressive disease or death [Approximately 3 years]
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with Adverse events (AEs)
기간: From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug
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To assess the safety of the sequence of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy |
From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug
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Objective Response Rate (ORR)
기간: From Day 1 until progression, or the last evaluable assessment in the absence of progression (Approximately 3 years)
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ORR is defined as the proportion of participants who have a confirmed complete response or partial response, as determined by the investigator per mRECIST. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy. |
From Day 1 until progression, or the last evaluable assessment in the absence of progression (Approximately 3 years)
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Overall Survival (OS)
기간: Day 1 to 18 months or until death (Approximately 3 years)
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OS is defined as the time from the start of TARE until the date of death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy. |
Day 1 to 18 months or until death (Approximately 3 years)
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Duration of Response (DoR)
기간: Time from first documented response until documented progression (Approximately 3 years)
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DoR is defined as the time from the date of first documented response (that is subsequently confirmed) until the date of documented progression per mRECIST as assessed by the investigator, or death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy. |
Time from first documented response until documented progression (Approximately 3 years)
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
- D933GC00002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 공유 기간
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 공유 액세스 기준
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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