- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02834546
Correlation Between Sorafenib Plasma Concentrations, Toxicity and Disease Control Rate in Patients Treated by Sorafenib for Hepatocellular Carcinoma (ACTES)
연구 개요
상태
정황
상세 설명
Sorafenib is the standard of care for the palliative treatment of HCC. The recommended dose of sorafenib in patients with HCC is 400 mg twice daily. Sorafenib dose-limiting toxicities include diarrhea, arterial hypertension and hand-foot syndrome. Owing a large inter-patient variability (near 50%) of sorafenib Area Under the Curve (AUC) over 12h, an over-exposure to sorafenib could explain acute toxicity. On the other hand, a suboptimal exposure could result in an insufficient anti-tumor activity as suggested by a recent study. This inter-patient variability of sorafenib pharmacokinetic is especially relevant in HCC. Indeed, most of HCC are developed on cirrhotic liver with often an impaired liver function, a decrease of albuminemia and sometimes ascitis. All these parameters are likely to impact the sorafenib pharmacokinetic. The aim of this pilot study is to correlate the sorafenib plasma concentration to observed toxicity and to the disease control rate in 100 patients.
The dose of sorafenib will be the recommended dose: 400 mg twice daily. Sorafenib daily doses will be only adjusted by the clinician on adverse event. Values of sorafenib AUC will not be transmitted to clinician.
Patients will be followed during 12 months with 5 visits: Week 4, Week 8, Week 16, Month 6 and Month 12. Adverse event related to sorafenib will be recorded and graded according to the NCI-CTC for Adverse Event during all the study period. Sorafenib plasma concentrations will be assessed at 4, 8 and 16 weeks. An additional dosage could be performed between W1 and W4, before dose modification, if a dose modification is necessary due to adverse events before W4.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Bordeaux, 프랑스
- Institut Bergonie
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Limoges, 프랑스
- CHU de LIMOGES
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Montpellier, 프랑스
- CHU de Montpellier
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Pessac, 프랑스
- CHU de Bordeaux
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Toulouse, 프랑스
- CHU de Toulouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Subjects > 18 years age
- Possibility of regular monitoring
- Ability to understand and willingness to sign written informed consent.
- Hepatocellular carcinoma histologically diagnosed or in case of inability to perform a histology by non-invasive radiological criteria endorsed by EASL/AASLD (a) presence of known cirrhosis and (b) identification of a focal hepatic lesion measuring at least 1cm in diameter with contrast uptake in the arterial phase and rapid wash out in the venous /late phase on two imaging techniques
- Patient not eligible for curative treatment (transplantation, resection, destruction or percutaneous chemo-embolization) or HCC still evolving after failure of a specific treatment
- ECOG ≤ 2
- Child-Pugh A or B
- Score BCLC B or C
Exclusion Criteria:
- Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
- Cirrhosis CHILD C
- Score BCLC D
- ECOG > 2
- Digestive bleeding within 30 days before inclusion
- Subject has had a liver transplant or waiting for a liver transplant
- Subject previously treated with sorafenib
- Childbearing or breastfeeding women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Patients with HCC treated with sorafenib
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Sorafenib plasma concentrations will be assessed at 4, 8 and 16 weeks by high performance liquid chromatography.
The pharmacology Unit of Bordeaux university hospital (Pr Molimard) is a French Center of reference for the dosage of TKI in the plasma
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Adverse events related to Sorafenib needing a dose adjustment or a symptomatic medication
기간: Up 8 weeks after sorafenib treatment introduction
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Up 8 weeks after sorafenib treatment introduction
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Adverse events notification
기간: Week 8, 16, month 6 and 12 after sorafenib treatment introduction
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Week 8, 16, month 6 and 12 after sorafenib treatment introduction
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Radiological response assessed by scan or MRI
기간: Week 8, 16, month 6 and 12 after sorafenib treatment introduction
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Week 8, 16, month 6 and 12 after sorafenib treatment introduction
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Progression-free survival time
기간: Up to month 12 after sorafenib treatment introduction
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Up to month 12 after sorafenib treatment introduction
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Overall survival
기간: Up to month 12 after sorafenib treatment introduction
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Up to month 12 after sorafenib treatment introduction
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공동 작업자 및 조사자
수사관
- 연구 의자: Eric FRISON, MD, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHUBX 2014/25
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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