- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03692689
Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer
Recombinant Anti-EGFR Monoclonal Antibody(SCT200) in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer : a Phase Ⅱ, Open-label, Single-arm, Multicenter Study
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Heilongjiang
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Harbin, Heilongjiang, 중국, 150081
- 모병
- Cancer Hospital Affiliated to Harbin Medical University
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연락하다:
- qingyuan zhang, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Able to provide written informed consent and can understand and comply with the requirements of the study;
- Women from 18 to 75 years old;
- Life expectancy of longer than 3 months ( clinical assessment);
- With an Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Histological or cytological diagnosis of relapsed/metastatic triple receptor negative breast cancer (TNBC).TNBC is defined negatively expression of estrogen(ER), progesterone(PR) and human epidermal receptor-2(HER2).If there is a pathology report of the metastasis, take the histopathology of the metastases as standard. Negative of ER and PR is defined as expression of ER,PR<1% of the tumor cells by immunohistochemistry (IHC). HER2-negative is defined as a score of 0 and 1+ by IHC, or IHC 2+ & fluorescent in situ hybridization (FISH)negative. If the ER2 test result is 0 or 1+ by IHC, FISH detection is optional, but the result must be negative.
- Participants has received prior anthracyclines and/or taxanes in first-line therapy. Disease progressed after latest chemotherapy. For adjuvant therapy/neoadjuvant therapy, disease relapse or progression during treatment or within 6 months after treatment is considered as failure of standard therapy.
- According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed at baseline.
- Adequate organ and marrow function as defined below:
Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal.
-Females: Post-menopausal, surgically sterile, non-pregnant and non-lactating.Women of childbearing potential must not be pregnant as assessed by a negative serum beta HCG test drawn upon admission to the hospital or up to 7 days prior to admission, and must agree to use adequate contraception (Oral contraceptives; intrauterine deviceshormonal; barrier method of birth control; abstinence) for the duration of study participation.and within 6 months after study.
Exclusion Criteria:
- Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;
- Patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis;
- Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study. (If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time less than 28 days,the subject is allowed to use it. Subjects who were enrolled in this study may start taking bisphosphonate or denosumab for bone metastases after the first assessment of the efficacy.
- Patients with other primary malignancies, except cured of basal cell carcinoma skin cancer or carcinoma in situ of cervix;
- Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;
- Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);
- Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.
- Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery.
- Patients treated with EPO, G-CSF or GM-CSF.
- Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia); Patients occurred myocardial infarction within 6 months.
- According to the investigator's judgment, patients have other coexisting severe and/or poorly controlled medical conditions (such as uncontrolled hypertension, uncontrolled diabetes, clotting/hemorrhagic disease, etc.).
- Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .
- Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
- Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
- Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;
- Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment;
- Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that there may be HIV infection, there is no need to detect);
- Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);
- Patients have alcohol or drug addiction;
- Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator,such as inability to comply with study and/or follow-up procedures;
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: SCT200
Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles.
After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
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Recombinant Anti-EGFR Monoclonal Antibody(SCT200)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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객관적 반응률(ORR)
기간: 일년
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ORR은 시험 치료 중 RECIST v1.1에 따라 완전 반응(CR) 또는 부분 반응(PR)을 달성한 환자의 비율로 정의됩니다.
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일년
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
부작용(AE)
기간: 일년
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AE는 NCI CTCAE v4.03에 따라 평가됩니다.
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일년
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무진보생존(PFS)
기간: 일년
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PFS는 RECIST v1.1 기준에 따라 SCT200의 첫 번째 투여부터 진행의 첫 번째 기록 날짜 또는 사망 날짜 중 먼저 발생하는 날짜까지의 시간으로 정의됩니다.
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일년
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질병 통제율(DCR)
기간: 일년
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RECIST v1.1 기준에 따라 안정적인 응답(SD), 부분 응답(PR) 또는 완전 응답(CR) 달성.
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일년
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전체 생존(OS)
기간: 일년
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OS는 SCT200의 첫 투여부터 모든 원인으로 인한 사망일까지의 시간으로 정의됩니다.
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일년
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응답 기간(DOR)
기간: 일년
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DOR은 환자가 RECIST v1.1에 따라 CR 또는 PR 기준을 처음 충족한 날짜부터 진행성 질환(PD)이 객관적으로 기록된 날짜 또는 사망 중 먼저 발생하는 날짜까지의 시간으로 정의됩니다.
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일년
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Time to Progression (TTP)
기간: 1 year
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TTP is defined as the time from first dose of SCT200 until the date of first documentation of progressive disease (PD), according to RECIST v1.1 criteria.
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: qingyuan zhang, MD, Cancer Hospital Affiliated to Harbin Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
- SCT200IITNBC
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
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. .
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