삼중음성유방암(TNBC) 참가자를 대상으로 선행 요법으로서 Famitinib과 병용하거나 병용하지 않은 Camrelizumab + 화학요법에 대한 연구 (BCTOP-T-N01)
삼중음성유방암(TNBC) 참가자를 대상으로 한 선행 요법으로서 Famitinib과 병용하거나 병용하지 않는 Camrelizumab + 화학요법의 무작위 공개 라벨 다기관 III상 연구
This is an open, randomized, controlled, multicenter Phase III clinical study. Eligible subjects were randomly assigned 1:1 to albumin-paclitaxel plus carboplatin and carrilizumab with or without famitinib neoadjuvant therapy. Stratification was performed at randomization according to the following factor: clinical stage of the tumor (stage II; Stage III) . Subjects who have completed neoadjuvant therapy and are suitable for surgery are required to undergo surgery. Subjects in the experimental group will continue to receive carrilizumab and famitinib until one year from the start of neoadjuvant therapy, and subjects in the control group will continue to receive carrilizumab until one year from the start of neoadjuvant therapy.
Subjects who completed neoadjuvant therapy were required to undergo imaging efficacy evaluation according to RECIST1.1 before surgery; subjects suitable for surgery received surgical treatment, and pathological evaluation of tumor efficacy was performed after surgery.
During the study treatment, if the subjects show disease progression, toxicity intolerance, withdrawal of informed consent, or the investigator determines that medication must be terminated, the study treatment will be terminated, and follow-up will continue, including disease recurrence and metastasis and safety follow-up.
Participants who complete surgical treatment will be followed for at least 2 years for event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), and safety assessment. Safety data should be collected from the signing of the informed consent until 28 days after the end of the study.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: chen li, MD
- 전화번호: +86-021-64175590
- 이메일: chen_li@fudan.edu.cn
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200032
- 모병
- Breast cancer institute of Fudan University Cancer Hospital
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연락하다:
- Zhi-Ming Shao, MD
- 전화번호: 86-21-641755901105
- 이메일: zhimingshao@yahoo.com
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연락하다:
- Lei Fan, MD
- 전화번호: 86-21-641755901105
- 이메일: cmchen@medmail.com.cn
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수석 연구원:
- Zhi-Ming Shao, MD
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부수사관:
- Li CHEN, MD
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Shanghai, Shanghai Municipality, 중국, 200032
- 모병
- Fudan University Shanghai Cancer Center Shanghai, China, 200032
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연락하다:
- Zhimin Shao, M.D.
- 전화번호: 88807 +86-021-64175590
- 이메일: zhimingshao@yahoo.com
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연락하다:
- Linxiaoxi Ma, M.D
- 전화번호: 63169 +86-021-64175590
- 이메일: mary2008white@126.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Inclusion Criteria:
ECOG Performance Status of 0-1. Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
Tumor stage: II-III. Adequate hematologic and organ function. Must be willing to use an adequate method of contraception for the course of the study.
Exclusion Criteria:
- Has a history of breast cancer. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].
Has a diagnosis of immunodeficiency or autoimmune diseases. Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
Severe pulmonary or cardiac disease. Known active hepatitis C virus, or known active hepatitis B virus. History of organ or bone marrow transplantation. Pregnant or breast-feeding women. Patients who have previously received VEGFR-like small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, Sunitinib, regorafenib, etc.) (except bevacizumab); Urine routine indicated urinary protein ≥2+ and confirmed urinary protein quantity > 1g at 24h;
공부 계획
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: Arm A
Camrelizumab Plus Chemotherapy and Famitinib |
camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib
다른 이름들:
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활성 비교기: Arm B
Camrelizumab Plus Chemotherapy |
Camrelizumab Plus Chemotherapy |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pathological complete response (pCR) rate
기간: Up to approximately 24 weeks
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the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery |
Up to approximately 24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MRI로 평가한 표적 병변에 대해 고형 종양(RECIST v1.1)에서 수정된 반응 평가 기준으로 평가한 반응자의 수.
기간: 최대 약 67주
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최대 약 67주
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Event-free Survival (EFS) as assessed by Investigator
기간: At least 2 years
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EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause. |
At least 2 years
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Disease-free Survival (DFS) as assessed by Investigator
기간: At least 2 years
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DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause. |
At least 2 years
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Distant Disease-free Survival (DDFS) as assessed by Investigator
기간: At least 2 years
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DDFS is defined as the time from surgery to distant recurrence, or death due to any cause. |
At least 2 years
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Objective response rate (ORR) in accordance with RECIST v1.1
기간: Up to approximately 24 weeks
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Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI. |
Up to approximately 24 weeks
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공동 작업자 및 조사자
스폰서
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
- BCTOP-T-N01
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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