JS207 Plus JS007 Versus Toripalimab Plus Bevacizumab as First-Line Treatment for Advanced Liver Cancer
2026년 9월 11일 업데이트: Shanghai Junshi Bioscience Co., Ltd.
A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of JS207 in Combination With JS007 Versus Toripalimab in Combination With Bevacizumab as First-line Treatment for Advanced Hepatocellular Carcinoma
This is a multicenter, randomized, open-label, controlled Phase III clinical study designed to evaluate the efficacy and safety of JS207 in combination with JS007 versus toripalimab in combination with bevacizumab as first-line treatment in participants with advanced HCC.
All study participants have unresectable locally advanced, recurrent, or metastatic HCC and have not previously received systemic anti-tumor therapy for advanced disease.
Approximately 560 participants are planned to be enrolled in this study. The JS207 + JS007 group (experimental group) and the toripalimab + bevacizumab group (positive control group) are each planned to enroll 280 participants.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This is a multicenter, randomized, open-label, active-controlled Phase III study in participants with unresectable locally advanced, recurrent, or metastatic hepatocellular carcinoma.Tumor images will be assessed by investigator and blinded independent central review (BICR). Treatment will continue until protocol-defined discontinuation criteria are met, for a maximum of 2 years. Participants will undergo tumor assessments, safety assessments, and survival follow-up.
Anti-tumor activity will be assessed by determining best overall response (BOR), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (BICR-PFS and INV Safety will be assessed through AEs, laboratory variables, physical examination findings, vital signs, 12-lead electrocardiogram, echocardiography, and ECOG performance status. The severity of AEs will be graded per NCI-CTCAE v6.0.
Participants in the JS207 + JS007 group (experimental group) will undergo plasma concentration assessments and immunogenicity assessments for JS207 and JS007.
The EORTC QLQ-C30, EORTC QLQ-HCC18, and EQ-5D-5L questionnaires will be used to assess participants' health-related quality of life (HRQOL).
연구 유형
연구 유형
중재적
등록 (추정된)
등록
560
단계
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Jiazheng Yan, Project Manager
- 전화번호: +86 158 2259 6147
- 이메일: jiazheng_yan@junshipharma.com
연구 연락처 백업
- 이름: Feng Li
- 전화번호: +86 186 2772 1499
- 이메일: feng_li@junshipharma.com
연구 장소
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Heilongjiang
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Harbin, Heilongjiang, 중국, 150081
- Harbin Medical University Cancer Hospital
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연락하다:
- Tongsen Zheng, Ph.D.
- 전화번호: +86 15134569619
- 이메일: ztsgcp@126.com
-
수석 연구원:
- Tongsen Zheng, Ph.D.
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200032
- Zhongshan hospital, Fudan university
-
연락하다:
- Jia Fan, Ph.D.
- 전화번호: +86 021 64041990
- 이메일: fan.jia@zs-hospital.sh.cn
-
연락하다:
- Guoming Shi, Ph.D.
- 전화번호: +86 13916969578
- 이메일: shi.guoming@zs-hospital.sh.cn
-
수석 연구원:
- Jia Fan, Ph.D.
-
부수사관:
- Guoming Shi, Ph.D.
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Voluntarily participate and sign a written informed consent form.
- Aged 18-75 years, regardless of sex.
- Histologically/cytologically confirmed HCC, or cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
- No prior systemic therapy for HCC.
- At least one measurable lesion per RECIST v1.1 criteria.
- Child-Pugh liver function grade A or grade B with a score ≤7, and no history of hepatic encephalopathy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
- Expected survival ≥ 12 weeks.
- Adequate hematologic and end-organ function.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use a highly effective contraceptive method during the study and for at least 6 months after the last dose. Female participants of childbearing potential must have a negative blood HCG test within 7 days prior to study enrollment and must not be breastfeeding.
Exclusion Criteria:
- Concomitant with the following study disease states: Known intrahepatic cholangiocarcinoma (ICC) or mixed-type liver cancer, sarcomatoid hepatocellular carcinoma, and fibrolamellar carcinoma of the liver; Presence of HCC central nervous system metastasis.
- Prior treatment-related toxicity not recovered to ≤ CTCAE Grade 1.
- Severe infection at screening.
Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically apparent moderate or greater ascites at screening.
-≥ Grade 3 (NCI-CTCAE v6.0) gastrointestinal or non-gastrointestinal fistula at screening.
- Severe unhealed wounds, active ulcers, or untreated fractures at screening.
- Severe cardiovascular or cerebrovascular disease:
- History of gastrointestinal bleeding within 6 months prior to the first dose, or definite tendency for gastrointestinal bleeding.
- Other obvious bleeding tendency or evidence of major coagulation disorders:
- Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
- Malignancy other than HCC within 5 years prior to the first dose.
- Confirmed or suspected moderate-to-severe pulmonary disease severely affecting pulmonary function.
- Active tuberculosis.
- Co-infection with hepatitis B and hepatitis C.
- Known history of human immunodeficiency virus (HIV) infection, prior allogeneic stem cell or solid organ transplantation, or other immunodeficiency.
- Known history of severe allergy to any monoclonal antibody.
- Other factors that, in the investigator's judgment, may affect study results or lead to forced premature termination of the study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: JS207 plus JS007
Drug:JS207, intravenous infusion Drug:JS007, intravenous infusion
|
PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.
CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.
|
|
활성 비교기: Toripalimab plus bevacizumab
Drug:Toripalimab, intravenous infusion Drug:Bevacizumab, intravenous infusion
|
PD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.
VEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS)
기간: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
|
Time from randomization to the first documented disease progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first.
Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
|
From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
|
|
Overall Survival (OS)
기간: From randomization to death from any cause; assessed up to 66 months.
|
Time from randomization to death from any cause.
After safety follow-up, survival status is assessed every 2 months until death, loss to follow-up, withdrawal of consent, or study termination.
|
From randomization to death from any cause; assessed up to 66 months.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival Assessed by the Investigator (INV-PFS)
기간: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
|
Time from randomization to first documented disease progression assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first.
Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
|
From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
|
|
Objective Response Rate Assessed by BICR (ORR)
기간: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR).
Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
|
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
|
Objective Response Rate Assessed by the Investigator (ORR)
기간: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR).
Responses and progression are assessed by the investigator per RECIST v1.1.
|
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
|
Disease Control Rate Assessed by BICR (DCR)
기간: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD).
Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
|
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
|
Disease Control Rate Assessed by the Investigator (DCR)
기간: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD).
Responses and progression are assessed by the investigator per RECIST v1.1.
|
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
|
Duration of Response Assessed by BICR (DoR)
기간: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
|
Time from the first documented complete response (CR) or partial response (PR) to first documented disease progression or death from any cause, whichever occurs first, among responders.
Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
|
From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
|
|
Duration of Response Assessed by the Investigator (DoR)
기간: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
|
Time from the first documented complete response (CR) or partial response (PR) to first documented disease progression or death from any cause, whichever occurs first, among responders.
Responses and progression are assessed by the investigator per RECIST v1.1.
|
From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
|
|
Number of Participants With Adverse Events
기간: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
Adverse events (AEs) are summarized by incidence, severity, and outcome.
Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
|
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
|
Number of Participants With Serious adverse events (SAEs)
기간: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
Serious adverse events (SAEs) are summarized by incidence, severity, and outcome.
Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
|
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
|
Number of Participants With Immune-related AEs
기간: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
Immune-related AEs are summarized by incidence, severity, and outcome.
Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
|
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Blood Concentrations of JS207
기간: Up to 27 months
|
Concentrations of JS207 in serum, measured using the validated bioanalytical assay.
|
Up to 27 months
|
|
Immunogenicity of JS207 assessed by the presence of antidrug antibodies (ADAs) for JS207
기간: Up to 27 months
|
Presence of antidrug antibodies (ADAs) for JS207 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
|
Up to 27 months
|
|
Immunogenicity of JS207 assessed by the presence of antidrug antibodies (NAb) for JS207
기간: Up to 27 months
|
Presence of antidrug antibodies (ADAs) for JS207 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
|
Up to 27 months
|
|
Blood Concentrations of JS007
기간: Up to 27 months.
|
Concentrations of JS007 in serum, measured using the validated bioanalytical assay.
|
Up to 27 months.
|
|
Immunogenicity of JS007 assessed by the presence of antidrug antibodies (ADAs) for JS007
기간: Up to 27 months.
|
Presence of antidrug antibodies (ADAs) for JS007 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
|
Up to 27 months.
|
|
Immunogenicity of JS007 assessed by the presence of antidrug antibodies (NAb) for JS007
기간: Up to 27 months
|
Presence of antidrug antibodies (ADAs) for JS007 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
|
Up to 27 months
|
|
EORTC QLQ-C30 Scores
기간: Up to 25 months
|
Patient-reported scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Scale and item scores range from 0 to 100.
|
Up to 25 months
|
|
EORTC QLQ-HCC18 Scores
기간: Up to 25 months.
|
Patient-reported scores on the EORTC hepatocellular carcinoma-specific quality-of-life questionnaire (QLQ-HCC18).
Symptom and problem scores range from 0 to 100.
|
Up to 25 months.
|
|
EQ-5D-5L
기간: Up to 25 months
|
There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analog scale (VAS) that measures health state.
|
Up to 25 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Jia Fan, Ph.D., Fudan University
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 (추정된)
연구 시작
2026년 10월 8일
기본 완료 (추정된)
기본 완료
2029년 10월 30일
연구 완료 (추정된)
연구 완료
2031년 10월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 9월 11일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 9월 11일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- JS207-017-III-HCC
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .