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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
3-Year Disease-Free Survival Rate
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Survival
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Кишечные заболевания
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Новообразования кишечника
- Заболевания прямой кишки
- Заболевания толстой кишки
- Колоректальные новообразования
- Органические химические вещества
- Гетероциклические соединения, 1-кольцо
- Гетероциклические соединения
- Нуклеиновые кислоты, нуклеотиды и нуклеозиды
- Координационные комплексы
- Дезоксицитидин
- Цитидин
- Пиримидиновые нуклеозиды
- Пиримидины
- Нуклеозиды
- Урацил
- Пиримидиноны
- Дезоксирибонуклеозиды
- Флуорурацил
- Капецитабин
- Оксалиплатин
- Иринотекан Sucrosofate
Другие идентификационные номера исследования
- CSPC-TJ-CRC-05
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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