Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation
2022년 5월 5일 업데이트: Xuehao Wang, The First Affiliated Hospital with Nanjing Medical University
An Exploratory Study of Bevacizumab Combined With FOLFOX4 in the Treatment of Recurrent Hepatocellular Carcinoma (HCC) After Liver Transplantation
This study is a single arm, single center, prospective and open exploratory study.
About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.
연구 개요
상태
아직 모집하지 않음
상세 설명
Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：
- Oxaliplatin: 85 mg/m2 , IV, D1，Q2W
- Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W
- Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W
연구 유형
중재적
등록 (예상)
15
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: yongxiang xia, doctor
- 전화번호: 86-025-68303211
- 이메일: yx_xia@njmu.edu.cn
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국, 210029
- Jiangsu Province Hospital
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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:
- adult patients with hepatocellular carcinoma who have received liver transplantation have postoperative radiographic or pathological evidence of recurrence;
- have not received the first line of standard treatment or have received the first line of standard treatment failure;
- at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2;
- Child-Pugh class A or B (Child-Pugh score ≤7 );
- adequate organ function;
- a predicted life expectancy of at least 3 months.
Exclusion Criteria:
- allergy to the study drugs or their expedients or severe allergy to other monoclonal antibodies;
- receipt of attenuated inactivated vaccines within 4 weeks of the start of the study or scheduled for such vaccination during the study;
- evident concern of GI bleeding (local active ulcer, Guaic test at least ++) or a history of GI bleeding within the preceding 6 months;
- uncontrolled pleural or peritoneal effusion;
- pulmonary tuberculosis, sarcoidosis, HIV infection, or active HBV or HCV infection;
- uncontrolled cardiac arrhythmia (including QTC interval ≥500 ms);
- hepatic encephalopathy;
- Known hepatocholangiocarcinoma, mixed hepatocellular and cholangiocellular carcinoma, fibrolamellar carcinoma, or a history of or concurrent cancer except cervical carcinoma in situ and cured basal cell carcinoma;
- pregnant or lactating women or women contemplating pregnancy;
- severe concomitant illness that jeopardizes patient safety or interferes with the completion of the study as deemed by the investigators;
- esophageal or gastric variceal bleeding with portal hypertension within the past 6 months.
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: Bevacizumab combine with FOLFOX4
Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：
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Patients received bevacizumab and FOLFOX4 every two weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate (ORR) ,Based on RECIST 1.1
기간: From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
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ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator analysis.
Responses (PR or CR) were confirmed no less than 4 weeks after the initial response.
CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 millimeter [mm] if it exists in a lymph node).
PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
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From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST
기간: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years )
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PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on RECIST 1.1 and mRECIST assessed by investigator review.
PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
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From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years )
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Disease Control Rate (DCR) ,Based on RECIST 1.1 and mRECIST
기간: Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years)
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the proportion of patients who achieved CR, PR, or SD as their best overall response
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Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years)
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Duration of Response (DOR) ,Based on RECIST 1.1 and mRECIST
기간: DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis.
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From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years)
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DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis.
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Overall Survival (OS)
기간: From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
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From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
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From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
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Time-to Response (TTR) Based on RECIST1.1 and mRECIST
기간: From date of first dose of study drug until CR or PR (up to approximately 2 years
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TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR.
It was evaluated according to RECIST1.1 and mRECIST assessed by investigate.
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From date of first dose of study drug until CR or PR (up to approximately 2 years
|
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Objective Response Rate (ORR) ,Based on mRECIST
기간: From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
|
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on mRECIST) assessed by investigator analysis.
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From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
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Safety as measured by number and grade of adverse events
기간: From first dose until 30 days after the last dose (up to approximately 2 years )
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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From first dose until 30 days after the last dose (up to approximately 2 years )
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Xuehao Wang, The First Affiliated Hospital with Nanjing Medical 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 (예상)
2022년 5월 1일
기본 완료 (예상)
2023년 5월 31일
연구 완료 (예상)
2024년 12월 31일
연구 등록 날짜
최초 제출
2022년 4월 20일
QC 기준을 충족하는 최초 제출
2022년 4월 26일
처음 게시됨 (실제)
2022년 5월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 5월 5일
마지막으로 확인됨
2022년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2021-SR-380
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. .