- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02406508
Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC
An International Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Sequential Melphalan Hydrochloride for Injection for Use With the Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
연구 개요
상세 설명
This is a single arm, open label, multi-center, phase 2 study to evaluate the safety and efficacy of sequential treatment with Melphalan/HDS followed by sorafenib in patients with unresectable hepatocellular carcinoma (HCC) confined to the liver.
Eligible patients will receive up to 3 Melphalan/HDS treatments. Each treatment cycle consists of 6 weeks with an acceptable delay for another 2 weeks before next planned treatment. The Melphalan/HDS treatment will be terminated in patients with progressive disease (PD), complete response (CR), and > 8 weeks delay of recovery from toxicity after last PHP treatment.
With the exception of patients with PD, all patients will be treated with sorafenib after completing the Melphalan/HDS treatment. Patients with PD will be managed with standard of care off-study by their treating physician.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Florida
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Tampa, Florida, 미국, 33612
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
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New York
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New York, New York, 미국, 10467
- Montefiore Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- HCC diagnosed by tissue or imaging study
- Unresectable HCC without extrahepatic disease based on CT
- At least one target lesion. In patients with prior loco-regional therapy, the target lesion(s) must be located in area(s) outside previous treatment
- Child-Pugh Class A in the absence of hepatoencephalopathy or clinically evident ascites
- Barcelona Clinic Liver Cancer (BCLC) stage B
- MELD Score < 15
- Eastern Cooperative Oncology Group Performance Status 0-1
- No prior systemic therapy for HCC
- No prior radiation therapy to the liver including Y90-, I131-based loco-regional therapy. Prior loco-regional therapy based on other technology for HCC, if any, must have been completed at least 4 weeks prior to baseline imaging
- Age ≥ 18 years
- Signed informed consent
Exclusion Criteria:
- Metastatic disease outside of liver
- Greater than 50% tumor burden in the liver by imaging
- History of orthotopic liver transplantation, clinical symptoms of portal hypertension, Whipple's procedure, hepatic artery anatomy incompatible with perfusion or known unresolved venous shunting
- Evidence of ascites on imaging study, or the use of diuretics for ascites
- Clinically significant encephalopathy
- History of allergies or known hypersensitivity to any components of melphalan or the components of the Melphalan/HDS system
- Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia
- Received an investigational agent for any indication within 30 days prior to first treatment
- Not recovered from side effects of prior therapy to ≤ grade 1 (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [NCI CTCAE v. 4.03]). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > grade 1
- Those with New York Heart Association functional classification II, III or IV; active cardiac conditions including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia
- History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia
- Uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism
- Active uncontrolled infection, including Hepatitis B, Hepatitis C infection. Patients with anti-HBc positive, or HBsAg but DNA negative are exception(s)
- History of bleeding disorders
- Brain lesions with a propensity to bleed
- Known esophageal varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer
- Previous malignancy within 3 years prior to enrollment, except for curatively-treated basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, bladder carcinoma in situ or breast cancer in situ
Inadequate hematologic function as evidenced by any of the following:
- Platelets < 125,000/µL
- Hemoglobin ≤ 10 g/dL, independent of transfusion or growth factor support
- Neutrophils < 1,500/µL
- Serum creatinine > 1.5 mg/dL
Inadequate liver function as evidenced by any of the following:
- Total serum bilirubin ≥ 2.0 mg/dL
- Prothrombin time International Normalized Ratio (INR) > 1.5
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) > 5 times ULN
- Serum albumin < 3.0 g/dL
- Alcohol consumption within 30 days of first study treatment, or refusing to abstain from alcohol for the duration of study treatment
- For female subjects of childbearing potential (i.e., have had a menstrual period within the past 12 months): a positive serum pregnancy test (β-human chorionic gonadotropin) within 7 days prior to enrollment; or unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment
- Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or unable to use appropriate contraception from screening until at least 30 days after last administration of study treatment
공부 계획
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 |
---|---|
실험적: Hepatic Delivery System Treatment followed by Sorafenib
Percutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System. Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 3 cycles of treatment. After the Melphalan/HDS treatment patients will be treated with sorafenib according to the package prescribing information. |
다른 이름들:
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Melphalan/HDS 치료 후 부작용이 발생한 환자 수.
기간: 2 년
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2 년
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Number of patients with adverse events after treatment with Sorafenib following treatment with Melphalan/HDS.
기간: 2 years
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2 years
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Melphalan/HDS 치료 비율의 객관적 반응률
기간: 2 년
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2 년
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Progression free survival in months of patients receiving Melphalan/HDS treatment followed by Sorafenib
기간: 2 years
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2 years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
AUC of melphalan after Melphalan/HDS treatment
기간: Baseline - prior to infusion. Infusion period - 10 min, 20 min, End of infusion. Washout period - 10 min, 20 min, 30 min. Post-procedure period - 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours, 3.5 hours, 5 hours.
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Pharmacokinetic study
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Baseline - prior to infusion. Infusion period - 10 min, 20 min, End of infusion. Washout period - 10 min, 20 min, 30 min. Post-procedure period - 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours, 3.5 hours, 5 hours.
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Quality of life questionnaires
기간: Baseline, Week 6 of each PHP cycle, Day 1 of every Sorafenib cycle, End of treatment, every 12 weeks in follow-up.
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Baseline, Week 6 of each PHP cycle, Day 1 of every Sorafenib cycle, End of treatment, every 12 weeks in follow-up.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Leslie Callahan, RN, Delcath Systems
연구 기록 날짜
연구 주요 날짜
연구 시작
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
- PHP-HCC-201
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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