Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
2021년 5월 21일 업데이트: Tianjin Medical University Cancer Institute and Hospital
A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.
연구 개요
상세 설명
This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect.
The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.
연구 유형
중재적
등록 (예상)
39
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Tianjin
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Tianjin, Tianjin, 중국, 300000
- 모병
- Tianjin Medical University Cancer Institute and Hospital
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연락하다:
- jihui Hao, MD
- 전화번호: 022-23524155
- 이메일: ec_tjcih@126.com
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연락하다:
- chuntao Gao, MD
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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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria.
- Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy
- ECOG score 0-2
- Adequate organ and bone marrow function
- The expected survival time is ≥ 12 weeks
- Had normal swallowing function, without dysfunction of gastrointestinal absorption
- Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures
Exclusion Criteria:
- The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel;
- The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy
- Known to be allergic to the active ingredients or excipients in this study.
- Had other active malignant tumors within 5 years before entering the study.
- Subject with cerebral metastasis
- Have a clear history of serious and uncontrolled other disease or mental disorders;
- Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy
- Other situations that the researcher considers inappropriate to participate in the research.
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SHR-1020 combined with albumin-bound paclitaxel
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SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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ORR (Objective Response Rate)
기간: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
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Containing the incidence of complete response (CR) and partial response (PR).
Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
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From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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DCR (Disease Control Rate)
기간: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
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Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
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From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
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PFS (Progression-Free-Survival)
기간: From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
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From date of treatment start until the date of progression or the date of death due to any cause.Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
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From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
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6mPFS
기간: Up to 6 months
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6-month- Progression-Free-Survival rate.
Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
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Up to 6 months
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OS (overall survival)
기간: From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
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From date of treatment start to any cause death or last follow-up.
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From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months
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Adverse events (per CTCAE v5.0 criteria)
기간: Up to 12months
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To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel
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Up to 12months
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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)
2021년 4월 22일
기본 완료 (예상)
2023년 7월 1일
연구 완료 (예상)
2023년 7월 1일
연구 등록 날짜
최초 제출
2021년 3월 17일
QC 기준을 충족하는 최초 제출
2021년 3월 22일
처음 게시됨 (실제)
2021년 3월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 5월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 5월 21일
마지막으로 확인됨
2020년 12월 1일
추가 정보
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