HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)
A Prospective Study of HCV-RNA Kinetics During Treatment With Sorafenib in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C
This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases.
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors.
The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.
調査の概要
詳細な説明
This is a prospective, open-label, non-interventional trial to evaluate HCV-RNA levels during treatment with Sorafenib in patients with advanced hepatocellular carcinoma.
Participants will receive Sorafenib 400mg orally twice daily. HCV-RNA (Hepatitis C Virus - Ribonucleic Acid) levels will be measured at baseline, week 2 of sorafenib, week 4 of sorafenib, week 6 of sorafenib, week 8 of sorafenib, week 12 of sorafenib, and 2 weeks after discontinuing sorafenib. HCV-RNA levels will be measured by drawing about 2 tablespoons of blood
During the study period, tumor assessments will be done by MRI (magnetic resonance imaging) or CT (computed tomography) scans at baseline and every 8 weeks.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Dana-Farber Cancer Institute
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Boston、Massachusetts、アメリカ、02215
- Brigham and Women's Hospital
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Boston、Massachusetts、アメリカ、02214
- Massachusetts General Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Histologically and/or radiologically confirmed advanced HCC
- Detectable HCV RNA with anti-HCV-positivity
- Life expectancy of at least 3 months
- Willing to use adequate contraception
Exclusion Criteria:
- Pregnant or breastfeeding
- Undetectable HCV RNA
- Uncontrolled hypertension
- Active or clinically significant cardiac disease
- Thrombolic, embolic, venous or arterial events within 6 months of informed consent
- Pulmonary hemorrhage/bleeding event (NCI-CTCAE grade 2 or higher) within 4 weeks before study entry
- Previously untreated or concurrent cancer except cervical cancer in situ, treated basal cell carcinoma or superficial bladder tumor
- Presence of non-healing wound, ulcer or bone fracture
- History of organ allograft
- Known or suspected allergy or hypersensitivity to any of the study drugs
- Any malabsorption condition
- Inability to comply with the protocol and/or not willing or not available for follow up
- Major surgery within 30 days prior to start of study drug
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Treatment Arm
Sorafenib taken orally twice per day
|
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decline in HCV-RNA Level
時間枠：up to 2 years
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Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.
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up to 2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Radiological Tumor Progression
時間枠：2 years
|
Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death.
Participants who are alive and progression-free at the date of last contact will be censored at this date.
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2 years
|
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Overall Survival
時間枠：2 years
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Overall survival is defined as the time period between enrollment and the date of death.
Participants who are still alive at last contact will be censored at this date.
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2 years
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline
時間枠：2 years
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The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported.
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2 years
|
協力者と研究者
捜査官
- 主任研究者：Andrew Zhu, MD, PhD、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。