Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation
2022年5月5日 更新者：Xuehao Wang、The First Affiliated Hospital with Nanjing Medical University
An Exploratory Study of Bevacizumab Combined With FOLFOX4 in the Treatment of Recurrent Hepatocellular Carcinoma (HCC) After Liver Transplantation
This study is a single arm, single center, prospective and open exploratory study.
About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.
調査の概要
状態
まだ募集していません
詳細な説明
Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：
- Oxaliplatin: 85 mg/m2 , IV, D1，Q2W
- Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W
- Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W
研究の種類
介入
入学 (予想される)
15
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：yongxiang xia, doctor
- 電話番号：86-025-68303211
- メール：yx_xia@njmu.edu.cn
研究場所
-
-
Jiangsu
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Nanjing、Jiangsu、中国、210029
- Jiangsu Province Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion criteria:
- adult patients with hepatocellular carcinoma who have received liver transplantation have postoperative radiographic or pathological evidence of recurrence;
- have not received the first line of standard treatment or have received the first line of standard treatment failure;
- at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2;
- Child-Pugh class A or B (Child-Pugh score ≤7 );
- adequate organ function;
- a predicted life expectancy of at least 3 months.
Exclusion Criteria:
- allergy to the study drugs or their expedients or severe allergy to other monoclonal antibodies;
- receipt of attenuated inactivated vaccines within 4 weeks of the start of the study or scheduled for such vaccination during the study;
- evident concern of GI bleeding (local active ulcer, Guaic test at least ++) or a history of GI bleeding within the preceding 6 months;
- uncontrolled pleural or peritoneal effusion;
- pulmonary tuberculosis, sarcoidosis, HIV infection, or active HBV or HCV infection;
- uncontrolled cardiac arrhythmia (including QTC interval ≥500 ms);
- hepatic encephalopathy;
- Known hepatocholangiocarcinoma, mixed hepatocellular and cholangiocellular carcinoma, fibrolamellar carcinoma, or a history of or concurrent cancer except cervical carcinoma in situ and cured basal cell carcinoma;
- pregnant or lactating women or women contemplating pregnancy;
- severe concomitant illness that jeopardizes patient safety or interferes with the completion of the study as deemed by the investigators;
- esophageal or gastric variceal bleeding with portal hypertension within the past 6 months.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
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実験的：Bevacizumab combine with FOLFOX4
Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：
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Patients received bevacizumab and FOLFOX4 every two weeks
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 |
|---|---|---|
|
Objective Response Rate (ORR) ,Based on RECIST 1.1
時間枠：From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
|
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator analysis.
Responses (PR or CR) were confirmed no less than 4 weeks after the initial response.
CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 millimeter [mm] if it exists in a lymph node).
PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
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From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 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 |
|---|---|---|
|
Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST
時間枠：From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years )
|
PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on RECIST 1.1 and mRECIST assessed by investigator review.
PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
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From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years )
|
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Disease Control Rate (DCR) ,Based on RECIST 1.1 and mRECIST
時間枠：Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years)
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the proportion of patients who achieved CR, PR, or SD as their best overall response
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Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years)
|
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Duration of Response (DOR) ,Based on RECIST 1.1 and mRECIST
時間枠：DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis.
|
From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years)
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DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis.
|
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Overall Survival (OS)
時間枠：From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
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From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
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From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
|
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Time-to Response (TTR) Based on RECIST1.1 and mRECIST
時間枠：From date of first dose of study drug until CR or PR (up to approximately 2 years
|
TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR.
It was evaluated according to RECIST1.1 and mRECIST assessed by investigate.
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From date of first dose of study drug until CR or PR (up to approximately 2 years
|
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Objective Response Rate (ORR) ,Based on mRECIST
時間枠：From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
|
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on mRECIST) assessed by investigator analysis.
|
From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
|
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Safety as measured by number and grade of adverse events
時間枠：From first dose until 30 days after the last dose (up to approximately 2 years )
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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From first dose until 30 days after the last dose (up to approximately 2 years )
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Xuehao Wang、The First Affiliated Hospital with Nanjing Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2022年5月1日
一次修了 (予想される)
2023年5月31日
研究の完了 (予想される)
2024年12月31日
試験登録日
最初に提出
2022年4月20日
QC基準を満たした最初の提出物
2022年4月26日
最初の投稿 (実際)
2022年5月2日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月11日
QC基準を満たした最後の更新が送信されました
2022年5月5日
最終確認日
2022年5月1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。