A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)
2026년 9월 22일 업데이트: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)
This study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC (KYLIN-02).
연구 개요
연구 유형
중재적
등록 (추정된)
590
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xin Shi
- 전화번호: +86-0518-82342973
- 이메일: xin.shi.xs3@hengrui.com
연구 연락처 백업
- 이름: Ying Sun
- 전화번호: +86-0518-82342973
- 이메일: ying.sun.ys1@hengrui.com
연구 장소
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Anhui
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Hefei, Anhui, 중국, 230000
- 모병
- Anhui Provincial Hospital
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수석 연구원:
- Shukui Qin
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수석 연구원:
- Lianxin Liu
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연락하다:
- Lianxin Liu
- 전화번호: +86-13845159888
- 이메일: liulx@ustc.edu.cn
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연락하다:
- Shukui Qin
- 전화번호: +86-13905158713
- 이메일: qinsk@csco.org.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Able and willing to provide a written informed consent.
- ≥ 18 years old, both male and female.
- Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
- At least one measurable lesion based on RECIST v1.1 criteria.
- Barcelona clinic liver cancer: Stage B or C.
- No previous systemic antitumor therapy for HCC.
- ECOG PS of 0-1.
- Child-Pugh score of A or B7.
- Expected survival period ≥ 12 weeks.
- Adequate organ function.
- Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.
Exclusion Criteria:
- Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
- Patients with other malignancies currently or within the past 5 years.
- With known severe allergic reactions to any other monoclonal antibodies.
- Patients with known CNS metastasis or hepatic encephalopathy.
- Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
- Patients with symptomatic ascites or pleural effusion.
- Patients with hypertension which cannot be well controlled by antihypertensives.
- Uncontrolled cardiac diseases or symptoms.
- Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
- Major vascular disease occurred in the 6 months before randomization.
- Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
- Major surgery within 28 days before randomization or expected to require major surgery during the study period.
- Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC > 15×109/L at baseline.
- Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
- Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
- Patients with other potential factors that may affect the study results.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Adebrelimab 및 Bevacizumab과 결합된 SHR-8068
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SHR-8068: injection, 50 mg/10 mL, intravenous infusion Adebrelimab: injection, 600 mg/12 mL, intravenous infusion Bevacizumab: injection, 100 mg/4 mL, intravenous infusion |
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활성 비교기: 신틸리맙과 베바시주맙의 병용
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Bevacizumab: injection, 100 mg/4 mL, intravenous infusion Sintilimab: injection, 100 mg/10 mL, intravenous infusion |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression Free Survival (PFS)
기간: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
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From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
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Overall survival (OS)
기간: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
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OS is defined as the time from randomization to death from any cause. |
From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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NCI-CTCAE v5.0에 따른 부작용(AE) 및 심각한 부작용(SAE)의 연구 약물에 대한 발생률, 중증도 및 관련성
기간: ICF 날짜부터 안전성 추적 관찰 종료 또는 새로운 항종양 치료 시작까지(최대 약 36개월)
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ICF 날짜부터 안전성 추적 관찰 종료 또는 새로운 항종양 치료 시작까지(최대 약 36개월)
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Time to Progression (TTP)
기간: From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
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TTP is defined as the time from randomization to the until first evidence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. |
From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
|
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Disease Control Rate (DCR)
기간: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
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DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. |
From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
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Objective Response Rate (ORR)
기간: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
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ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. |
From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
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Duration of Response (DoR)
기간: From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)
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DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first). |
From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)
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Time to Response (TTR)
기간: From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)
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TTR is defined as time from the randomization of Complete Response (CR) or Partial Response (PR) by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. |
From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 10월 28일
기본 완료 (추정된)
2026년 10월 1일
연구 완료 (추정된)
2030년 12월 1일
연구 등록 날짜
최초 제출
2024년 9월 26일
QC 기준을 충족하는 최초 제출
2024년 9월 26일
처음 게시됨 (실제)
2024년 10월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 22일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SHR-8068-301
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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