Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases
An Exploratory Clinical Study of Hepatic Arterial Infusion of Liposomal Irinotecan Combined With Oxaliplatin and Capecitabine as Postoperative Adjuvant Therapy for Colorectal Cancer Liver Metastases
This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine as postoperative adjuvant therapy in patients with colorectal cancer liver metastases after radical resection.
Eligible participants must have histologically confirmed colorectal cancer liver metastases and have completed radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment. Postoperative imaging must show no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease. Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine every 21 days for 2 to 4 cycles. After 2 cycles, treatment continuation will be determined by the investigator based on efficacy and tolerability.
調査の概要
状態
詳細な説明
Colorectal cancer commonly metastasizes to the liver, and recurrence after radical resection of colorectal cancer liver metastases remains frequent, particularly in the liver. Systemic adjuvant chemotherapy is commonly used after resection to eliminate potential micrometastatic disease; however, systemic chemotherapy may have limited local efficacy in the liver and may be associated with systemic toxicity.
Hepatic arterial infusion chemotherapy delivers chemotherapy directly into the hepatic arterial supply. Because liver tumors are mainly supplied by the hepatic artery, this approach may increase local drug concentration in the liver while reducing systemic exposure. Liposomal irinotecan is a liposomal formulation of irinotecan designed to improve drug stability, prolong circulation, enhance tumor accumulation, and potentially reduce systemic toxicity.
This study will explore whether hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine can improve disease-free survival and hepatic recurrence-free survival while maintaining an acceptable safety profile in patients at high risk of hepatic recurrence after radical resection of colorectal cancer liver metastases.
研究の種類
入学 (推定)
段階
- フェーズ2
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 to 75 years.
- Completion of radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment, with postoperative imaging showing no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease.
- Histologically confirmed colorectal cancer liver metastases.
- ECOG performance status of 0 or 1.
- Expected survival of at least 3 months.
- Clinical risk score of 3 or higher.
- Adequate bone marrow function, defined as absolute neutrophil count >2 × 10^9/L, hemoglobin >9.0 g/dL, and platelet count >100 × 10^9/L.
- Adequate renal function, defined as serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥30 mL/min according to the Cockcroft-Gault formula.
- Adequate hepatic function, defined as serum bilirubin ≤1.5 × the upper limit of normal, transaminases ≤2.5 × the upper limit of normal or ≤5 × the upper limit of normal if liver metastasis is present, and alkaline phosphatase ≤5 × the upper limit of normal.
- Female participants must not be pregnant or breastfeeding. Women of childbearing potential and male participants must use effective contraception during the study and for 6 months after completion of study treatment.
- Good compliance, ability to understand the study procedures, and willingness to sign written informed consent.
Exclusion Criteria:
- Contraindication to capecitabine, oxaliplatin, or irinotecan.
- Any history of hepatic interventional therapy, including transarterial infusion, hepatic arterial infusion, or transarterial chemoembolization.
- Receipt of adjuvant chemotherapy containing irinotecan after resection of the primary tumor, or receipt of adjuvant therapy without irinotecan with the last dose administered within 3 months before enrollment.
- Dihydropyrimidine dehydrogenase deficiency.
- History of severe cardiovascular disease resulting in inability to tolerate treatment.
- Peripheral neuropathy greater than Grade 1.
- History of another malignancy within the previous 5 years, except cured carcinoma in situ or basal cell carcinoma of the skin.
- History of allogeneic organ transplantation.
- Requirement for renal dialysis.
- Breastfeeding, pregnancy, or inadequate contraception in women of childbearing potential.
- Uncontrolled concomitant disease, including but not limited to severe active or uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, uncontrolled diabetes, or psychiatric illness that may affect study compliance.
- Participation in another clinical trial currently or within 4 weeks before enrollment.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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：Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine
Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine.
Each treatment cycle is 21 days.
Treatment will be administered for 2 to 4 cycles.
After 2 cycles, the investigator will decide whether to stop treatment or continue for another 2 cycles based on efficacy and tolerability.
|
Liposomal irinotecan 50 mg/m^2 will be administered by hepatic arterial infusion over 90 minutes on Day 1 of each 21-day cycle.
Oxaliplatin 100 mg/m^2 will be administered by intravenous infusion on Day 1 of each 21-day cycle.
Capecitabine 1000 mg/m^2 will be administered orally twice daily on Days 1 to 14 of each 21-day cycle.
Hepatic arterial infusion chemotherapy will be performed to deliver liposomal irinotecan directly through the hepatic artery as part of postoperative adjuvant treatment.
|
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 |
|---|---|---|
|
3-Year Disease-Free Survival Rate
時間枠：3 years from initiation of study treatment.
|
The 3-year disease-free survival rate is defined as the proportion of participants who remain free of tumor recurrence, metastasis, or disease progression at 3 years after initiation of study treatment.
|
3 years from initiation of study treatment.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival
時間枠：From enrollment to death from any cause, assessed for up to 3 years.
|
Overall survival is defined as the time from enrollment to death from any cause.
Participants who are alive at the end of the study will be censored at the date they were last known to be alive.
|
From enrollment to death from any cause, assessed for up to 3 years.
|
|
Hepatic Recurrence-Free Survival
時間枠：From completion of study treatment to first hepatic recurrence, assessed for up to 3 years.
|
Hepatic recurrence-free survival is defined as the time interval from completion of study treatment to the first recurrence of tumor in the liver.
|
From completion of study treatment to first hepatic recurrence, assessed for up to 3 years.
|
|
Incidence and Severity of Adverse Events
時間枠：From the first dose of study treatment through the end-of-treatment visit and follow-up period, assessed for up to 3 years.
|
Safety will be assessed by the incidence and severity of adverse events, including overall adverse events, adverse events by grade, Grade 3 or higher adverse events, and serious adverse events.
Adverse events will be graded according to NCI CTCAE version 5.0.
|
From the first dose of study treatment through the end-of-treatment visit and follow-up period, assessed for up to 3 years.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CSPC-TJ-CRC-05
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
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