Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Официальное название

A Randomized, Multicenter Clinical Study of Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Обзор

This study enrolled patients with locally advanced rectal cancer. The experimental group received irinotecan liposomes combined with standard total neoadjuvant therapy (TNT), while the control group received standard TNT. The study endpoints were the complete response rate (cCR + pCR), 3-year event-free survival (EFS) rate, and overall survival (OS). The aim was to compare the efficacy and safety of irinotecan liposomes combined with or without standard TNT.

Вмешательства

• Препарат NALIRI
  Irinotecan liposomes
• Лучевая терапия LCRT
  Long-course concurrent chemoradiotherapy
• Препарат FOLFOX
  Fluorouracil/Leucovorin, Oxaliplatin (5-FU/LV, OX)

Первичные конечные точки

• Complete Response rate（CR） [Срок оценки: cCR: before the surgery, and up to 4 weeks after the end of completation of total neoadjuvant therapy (TNT) for cCR. pCR: after the surgery.]

Вторичные конечные точки (1)

• 3-year event-free survival (3y-EFS) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.]

Критерии участия

Критерии включения

• Age ≥ 18 years and ≤ 75 years, both male and female are eligible;
• Histologically confirmed rectal adenocarcinoma;
• Clinical stage assessed by MRI as T3-4 or N+ (according to the 8th edition of the AJCC);
• Distance from the lower edge of the tumor to the anal verge ≤ 10 cm;
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;
• UGT1A1\*6 and UGT1A1\*28 gene phenotypes are either wild-type (GG+6/6) or single-site mutant (GG+6/7 or GA+6/6);
• No prior anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.;
• Normal function of major organs.

Критерии исключения

• Previous or ongoing treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
• Known MSI-H (high microsatellite instability) by genetic testing or dMMR (deficient mismatch repair) by immunohistochemistry.
• Known hypersensitivity, allergic reaction, or contraindication to irinotecan liposomes/vehicle, irinotecan, other liposomal products, 5-FU, leucovorin, oxaliplatin, or any of these agents.
• Uncontrolled cardiac symptoms or disease.
• Severe infection (CTCAE > Grade 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging showing active pulmonary inflammation; signs and symptoms of infection within 14 days prior to the first use of the study drug or requiring oral or intravenous antibiotic therapy, excluding prophylactic use of antibiotics.
• Severe gastrointestinal dysfunction (inflammation or diarrhea greater than Grade 1).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07074353 · CinClare-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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