A Randomized, Multicenter Clinical Study of Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Complete Response rate（CR）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
NALIRI-TNT
Irinotecan Liposomes+Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy
干预措施: NALIRI (Drug)
NALIRI-TNT
Irinotecan Liposomes+Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy
干预措施: LCRT (Radiation)
NALIRI-TNT
Irinotecan Liposomes+Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy
干预措施: FOLFOX (Drug)
TNT
Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy
干预措施: LCRT (Radiation)
TNT
Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy
干预措施: FOLFOX (Drug)
结局指标
主要结局
Complete Response rate（CR）
时间窗: 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.
Clinical Complete Response rate（cCR）+ Pathological Complete Response rate （pCR）
次要结局
- 3-year event-free survival (3y-EFS)(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.)
研究者
Ji Zhu
Coordinating Investigator
Zhejiang Cancer Hospital