Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.
详细描述
This is a Phase II clinical study to evaluate the efficacy and safety of the combination regimen of irinotecan liposome injection in the first-line treatment of metastatic colorectal cancer. Patients will receive liposomal injections of irinotecan 70mg/m^2 d1, bevacizumab 5mg/kg d1, LV 400mg/m^2 d1, 5-FU 400mg/m^2, then 2400mg/m^2, continuous intravenous infusion for 46-48h, d1-2. 86 eligible patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~85 years old.
- •Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma.
- •RAS/BRAF v600e mutant or right half colon cancer is known.
- •pMMR/MSS is known.
- •The unresectable stage of metastatic disease has not received any systemic antitumor therapy.
- •For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 6 months removed from the date of last administration of neoadjuvant or adjuvant therapy.
- •ECOG 0~1, patients ≥75 years old need an ECOG score of 0
- •The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria.
- •Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10^9/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; The total bilirubin level doesn't exceed the upper limit of the agency's normal range; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40 ml/min (calculated according to Cockroft-Gault)
- •Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form.
排除标准
- •Known or suspected central nervous system metastasis.
- •Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
- •Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment.
- •Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 I or below(except hair loss and peripheral neuropathy).
- •The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment.
- •Severe gastrointestinal dysfunction, gastrointestinal perforation, intraperitoneal abscess, and fistula.
- •Intestinal obstruction, signs and symptoms of intestinal obstruction, or the stent has been previously implanted and the stent has not been removed before the screening period.
- •Interstitial lung disease.
- •Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding).
- •Patients with fluid accumulation that couldn't reach a stable state but small amount of ascites on imaging without clinical symptoms could be enrolled.
- •Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc.
- •Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer.
- •Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding.
- •The researchers didn't consider it appropriate to participate in this study.
研究组 & 干预措施
irinotecan liposome injection combined with 5-FU/LV+ bevacizumab
Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles.
干预措施: Irinotecan Liposome (Drug)
irinotecan liposome injection combined with 5-FU/LV+ bevacizumab
Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles.
干预措施: 5-FU (Drug)
irinotecan liposome injection combined with 5-FU/LV+ bevacizumab
Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles.
干预措施: LV (Drug)
irinotecan liposome injection combined with 5-FU/LV+ bevacizumab
Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 months
To investigate antitumor efficacy of study.
次要结局
- Disease control rate(From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first. Assessed up to 4 months)
- R0 resection(From the first dose to the surgery. Assessed up to 6 months.)
- Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0(From the first dose to completed 8 cycles treatment. Assessed up to 5 months.)
- Progression free survival(From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 30 months.)
- Overall survival(From initial medication to the date of death from any cause. Assessed up to 30 months.)
- Percentage of patients undergoing surgery.(From the first dose to completed 8 cycles treatment. Assessed up to 5 months.)