Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery (PUMP IV)
補助肝動脈注入ポンプ化学療法を使用した肝内胆管癌の部分的肝摘出後の肝臓の再発の予防 - ポンプIV試験
The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are:
- Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery?
- Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients?
- Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life?
Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Bas Groot Koerkamp, MD, PhD
- 電話番号：+31(0)107031810
- メール：b.grootkoerkamp@erasmusmc.nl
研究連絡先のバックアップ
- 名前：Thomas C Zwaan, MD
- 電話番号：+31(0)621218051
- メール：t.zwaan@erasmusmc.nl
研究場所
-
-
South Holland
-
Rotterdam、South Holland、オランダ、3015GD
- 募集
- Erasmus Medical Center
-
コンタクト：
- Bas Groot Koerkamp, MD, PhD
- 電話番号：+31(0)107031810
- メール：b.grootkoerkamp@erasmusmc.nl
-
コンタクト：
- Thomas C Zwaan, MD
- 電話番号：+31(0)621218051
- メール：t.zwaan@erasmusmc.nl
-
主任研究者：
- Bas Groot Koerkamp, MD, PhD
-
-
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:
- 18 years or older
- ECOG or WHO performance status 0 or 1
- Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.
- Patient is able to undergo a laparotomy.
- Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.
- Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old)
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^ 9/L
- White blood cell count (WBC) ≥ 2.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Glomerular filtration rate (GFR) ≥ 30 ml/min
- Haemoglobin (Hb) ≥ 5.5 mmol/L
- Total bilirubin ≤ 25 µmol/L
- Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations.
Exclusion Criteria:
- Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible.
- Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years.
- Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
- Prior hepatic radiation, ablation, or resection for iCCA.
- Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.
- (Partial) portal vein thrombosis in future liver remnant.
- Pregnant or lactating women.
- History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
- Organ allografts requiring immunosuppressive therapy.
- Serious infections (uncontrolled or requiring treatment).
- Participation in another interventional study for iCCA with survival as outcome.
- Participation in another prospective study with an interventional medical product.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
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：Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy)
Surgery + chemo pump |
Participants in this arm will receive in addition to standard care (surgery) a chemo pump. This pump will provide participants with 4 cycles of treatment with chemotherapy (Floxuridin), each lasting 4 weeks. Total treatment with chemotherapy will last 16 weeks (approx. 4 months)
他の名前：
|
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 |
|---|---|---|
|
Two-year hepatic recurrence free survival (hRFS)
時間枠：From pump implantation until 2 years after that surgery
|
The percentage of patients who do not have return of disease in the liver two years after surgery. The time frame is defined as the period between pump implantation and return of disease in the liver. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples. |
From pump implantation until 2 years after that surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall recurrence free survival (RFS)
時間枠：From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)
|
The percentage of patients who do not have return of disease in the given time frame. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples. |
From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)
|
|
Overall survival (OS)
時間枠：From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)
|
OS is defined as the interval between pump implantation and the date of death (by any cause) or date of last follow-up |
From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)
|
|
Post-operative complications
時間枠：From pump implantation until 90 days after surgery
|
All complications rated Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery. |
From pump implantation until 90 days after surgery
|
|
Chemotherapy related adverse events (AEs)
時間枠：From inclusion until 4 weeks after the end of treatment with chemotherapy
|
Chemotherapy related adverse events (AEs) will be collected if they are grade III or higher according to CTCAE version 5.0 |
From inclusion until 4 weeks after the end of treatment with chemotherapy
|
|
Proportion of patients started with HAIP chemotherapy
時間枠：From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump
|
The number of patients that could receive at least 1 cycle of HAIP chemotherapy with floxuridin |
From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump
|
|
Quality of life: EORTC QLQ-30
時間枠：From inclusion until 5 years after surgery
|
After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This validated instrument includes 30 items covering functional domains, symptom scales, and global health status. Scores range from 0 to 100, with higher scores on the global health and functional scales indicating better quality of life. After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years. |
From inclusion until 5 years after surgery
|
|
Quality of life: EQ-5D
時間枠：From inclusion until 5 years after surgery
|
After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the EuroQol 5-Dimension (EQ-5D) questionnaire, a standardized measure of health-related quality of life. The EQ-5D includes five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The resulting health state is converted into an index score ranging from 0 (equivalent to death) to 1 (perfect health), though negative scores are possible. After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years. |
From inclusion until 5 years after surgery
|
|
Cost-effectiveness
時間枠：From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)
|
An assessment of the cost-effectiveness of HAIP chemotherapy for patients with iCCA will be made |
From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)
|
|
Predictive biomarkers in the blood for efficacy of HAIP chemotherapy
時間枠：From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)
|
A total of five additional blood samples will be collected. These samples will be collected:
|
From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)
|
|
Predictive biomarkers from liver tissue for efficacy of HAIP chemotherapy
時間枠：From resection until 25 years after (conform applicable laws)
|
Additionally, tumor tissue will be collected from the removed part of the liver during the surgery. These tissue samples will be stored for further research into biomarkers. |
From resection until 25 years after (conform applicable laws)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Bas Groot Koerkamp, MD, PhD、Erasmus Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MEC-2024-0324
- 2024-513726-33-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The decision on sharing IPD has not been made within the trial team. Once this decision is made, we will update this part.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。