Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
Phase II Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC. With the development of new radiotherapy (RT) technique, RT can be more safely given to patients with larger tumor burden. Thus, TACE combined with RT has been suggested for treating large HCC. Based on the results of these studies, RT could achieve a tumor response rate of 50 % to 70 %. However, it has not been definitively shown to prolong the overall or disease-free survival due to lack of a phase III clinical trial. In contrast, a retrospective clinical investigation with molecular study suggests that sublethal dose of RT promoted HCC growth outside RT field.
Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo. It is interesting to recognize the combined therapeutic effect of RT with sorafenib. Based on several preclinical experiments, tumor angiogenesis inhibitors seem to be synergistic with irradiation when using before RT, concurrently with RT, or after RT. Thus, the investigators design a single-arm phase II clinical trial to investigate the efficacy of combined RT with sorafenib.
The eligibility criteria are patients with unresectable HCC; good performance status; no prior radiotherapy for the liver; clinical measurable tumor; good liver function and good compliance. After entering this study, the testee will receive RT to hepatic tumor with concurrently sorafenib with a dose of 400 mg twice daily. Hepatic RT will be performed with a daily fraction size of 2.0 to 2.5 Gy to a total dose of 46 Gy to 60 Gy. After RT, maintenance sorafenib with a dose of 400 mg twice daily will be ongoing. Sorafenib will be continued until the occurrence of clinical or radiologic progression, or the occurrence of either unacceptable adverse events or death. Minimum maintenance duration of 6 months is recommended, but not mandatory.
연구 개요
상세 설명
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Taichung, 대만, 404
- 모병
- Shang-Wen Chen
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연락하다:
- Shang-Wen Chen, MD
- 전화번호: 7450 886-4-22052121
- 이메일: vincent1680616@yahoo.com.tw
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부수사관:
- Yu-Cheng Kuo
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부수사관:
- Ji-An Liang, MD
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Tainan, 대만, 700
- 모병
- Li-Ching Lin
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연락하다:
- Li-Ching Lin, MD
- 이메일: liching51@yahoo.com.tw
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Taipei, 대만, 100
- 모병
- Jeng-Fong Chiou
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연락하다:
- Jeng-Fong Chiou, MD;PhD
- 이메일: sjfchiou@xuite.net
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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:
- Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TACE. A maximal tumor diameter > 3.0 cm.
- Age: 20 ~ 69 years.
- ECOG 0 or 1.
- Life expectancy of at least 12 weeks.
- Child-Pugh A or B (preferentially score ≦ 7).
- Cancer of the Liver Italian Program (CLIP) score ≦ 3.
Pretreatment liver function test and renal function test:
- Total bilirubin < 1.5 times the upper limit of normal (ULN)(≦ 3.0 (ULN) in patients treated by biliary drainage for obstructive jaundice)
- GOP/GPT ≦ 5 X of upper limit of normal range
- Alkaline phosphatase ≦ 4X of upper limit of normal range
- Prothrombin time/partial prothrombin time < 1.5 X of ULN
- Serum Creatinine ≦ 1.0 x ULN
Pretreatment blood count:
- Hemoglobulin ≧ 9 g/dl
- Absolute neutrophil count ≧ 1500/mm3
- Platelet count ≧ 50,000/mm3
- Subjects with at least one uni-dimensional or bi-dimensional measurable lesion. Lesion must be measured by CT scan or MRI.
- Patients must fully recover from prior therapy that given > 4 weeks before enrollment.
- Signed informed consent must be obtained prior to any study related procedures.
Exclusion Criteria:
- Child-Pugh C
- CLIP score ≧ 4
- Patients with evidence of extrahepatic or metastatic disease
- Patients with evidence of massive ascites
- Patients receiving previous irradiation to liver
- Patients with previous use of Thalidomide less than 6 months from entering of the study
- History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted)
- Active clinically serious infections ( > grade 2 CTC version 2)
- Patients undergoing renal dialysis
- Patients with evidence or history of bleeding diathesis
- Prior treatment with EGFR TKIs or VEGFR TKIs
- Hypertension uncontrolled by medical therapy
- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper.
- Chemotherapy or immunotherapy or other systemic anti-cancer therapy within 4 weeks.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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radiotherapy efficacy
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Concurrent and maintenance sorafenib 400mg twice daily
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response rate
기간: 6 months
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Disease progression-free survival
기간: 2 years
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Disease progression-free survival: Patients with the evidence of clinical or radiographic progressive disease will be defined as disease progression. The average time period for the follow-up will be two years. |
2 years
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Overall survival
기간: 2 years
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Participants will be followed.
The average time period will be two years.
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shang-Wen Chen, MD, Department of Radiation Oncology, China Medical University Hospital
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Radiotherapy-Sorafenib
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