- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01924624
Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma
Adjuvant Therapy With Thalidomide After Curative Resection of Hepatocellular Carcinoma.: a Randomized Controlled Trial
연구 개요
상세 설명
A number of modalities for preventing HCC recurrence after resection have been proposed and analyzed. Both preoperative and adjuvant transcatheter arterial chemoembolization (TACE) were found to be unable to reduce the risk of postoperative recurrence significantly, or confer a survival advantage. Vitamin K (VK) is a fat-soluble vitamin that regulates clotting factor production by acting as a coenzyme for a VK dependent carboxylase that catalyzes carboxylation of glutamic acid residues into gamma-carboxyglutamic acid. The findings in vitro have indicated that VK2 has an antiproliferative effects against hepatoma cell lines, but its efficacy in suppressing HCC recurrence was not confirmed in human studies. Interferon has a variety of biologic properties, including antiviral, immunomodulatory, antiproliferative, antiangiogenic and tumoricidal effects. It is reported that interferon is effective in preventing the development of HCC recurrence after its curative treatment in HCV-related cirrhosis. However, interferon treatment also has side-effects, including flu-like symptoms, fatigue, neutropenia, thrombocytopenia, depression, bone marrow suppression, and unmasking or exacerbation of autoimmune illnesses, which lead either to treatment disruption or dose modification. Polyprenoic acid, an acyclic retinoid, reportedly is effective in prevention of second primary hepatomas, but long-term safety and efficacy data are lacking.
Thalidomide possesses immunomodulatory,anti-inflammatory, and antiangiogenic properties.It has successfully been applied for the treatment of various malignancies including HCC.To investigated whether postoperative adjuvant therapy with Thalidomide could inhibite the recurrence of HCC after radical resection,we planed to conduct this clinical trial.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yan-Ming Zhou, MD
- 전화번호: 8605922139908 8605932139708
- 이메일: zhouymsxy@sina.cn
연구 장소
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Fujian
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Xiamen, Fujian, 중국, 361003
- 모병
- First Affiliated Hospital of Xiamen University
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연락하다:
- Yan-Ming Zhou, MD
- 이메일: zhouymsxy@sina.cn
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수석 연구원:
- Bin Li
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수석 연구원:
- Lu-Peng Wu
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수석 연구원:
- Xiu-Dong Li
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수석 연구원:
- Xu Su
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18-75 years old,male and female
- Patients who did not receive any anti-tumor therapies prior to the surgery (including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy and other anti-tumor therapy) resection of hepatocellular carcinoma
- Patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis
- Sign the informed consent
Exclusion Criteria:
- Women who were pregnant or breast-feeding
- signs showing recurrence or metastasis one month after surgery
- Recurrent HCC
- Patients unable to take drug orally
- Patients inappropriate to participate in the trial upon the investigator's judgment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Thalidomide
Thalidomide 100mg per day after the radical resection HCC
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Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period
다른 이름들:
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활성 비교기: Control
No adjuvant Thalidomide treatment after curative hepatic resection
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Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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무병 생존
기간: 5 년
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5 년
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2차 결과 측정
결과 측정 |
기간 |
---|---|
전반적인 생존
기간: 5 년
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5 년
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yanmng Zhou, MD, Xiamen University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .