The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung Cancer
A Phase II Clinical Study of Adebelizumab Combined With Other Anti-tumor Treatments as a Perioperative Treatment for Resectable Non-small Cell Lung Cancer
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Yanhua Huang
- 전화번호: 0518-82342973
- 이메일: Yanhua.Huang@hengrui.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200000
- Shanghai Pulmonary Hospital
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수석 연구원:
- Chang Chen
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ;
- At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can.
The ECOG score was 0 or 1. 4. Patients with histopathologically or cytologically confirmed Stage II, IIIA, or select Stage IIIB (AJCC 9th edition) non-small cell lung cancer who are candidates for curative-intent R0 surgical resection.
5.Combined genetic requirements : non-squamous cell carcinoma subjects must undergo EGFR gene detection and ALK gene and or immunohistochemical detection.
6.Can provide tumor tissue specimens, which can be archived or freshly obtained specimens for biomarker detection.
7.According to the RECIST v1.1 standard, subjects must have measurable target lesions examined by CT or MRI. Tumor imaging evaluation was performed within 28 days before the first administration.
8.There is sufficient hematology and organ function, as defined by the results of laboratory tests, to be completed within 7 days prior to the first dose of treatment : 9.Women of childbearing age must have a serum pregnancy test within 7 days before the first administration, and the result is negative. Women of childbearing age and men whose partners are women of childbearing age must agree to use an efficient method of contraception from the date of signing the informed consent to at least 26 weeks ( female subjects ) or 14 weeks ( male subjects ) after the last administration.
Exclusion Criteria:
- Small cell lung cancer ( SCLC ) and NSCLC mixed tumors confirmed by histology or cytology contain non-NSCLC pathological types such as small cell components.
3.Have previously received systematic anti-tumor therapy for non-small cell lung cancer other than this study ( including clinical research drugs ) ; 4.Participants who had received or planned to receive local treatment such as chest radiotherapy or ablation ;
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: PART A
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Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection
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실험적: PART B
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Adebrelimab Injection combined with HRS-7058 Capsule
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection.
기간: All results are expected to be obtained in the last participant three months after surgery.
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All results are expected to be obtained in the last participant three months after surgery.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Event-free survival (EFS)
기간: In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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EFS is defined as the time from the first dose to any of the following events: any progression of disease precluding surgery; progression or recurrent disease based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after surgery; or death from any cause.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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Disease-free survival (DFS) as assessed byinvestigator
기간: In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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DFS is defined as the time from firste dose to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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Objective response rate (ORR): assessed by the investigator
기간: In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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Overall Survival (OS)
기간: In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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OS is defined as the time from first dose to death due to any cause.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SHR-1316-207
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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