Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy
研究概览
简要总结
To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.
详细描述
Primary Objective:
• To assess 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy
Secondary Objectives:
- To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients
- To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients
- To evaluate the proportion of ctDNA-negative at 1-year post-resection
- To compare survival of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls
- To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement
- To delineate the pattern of disease recurrence
- To assess ctDNA sensitivity and specificity for predicting disease recurrence
- To evaluate MDASI-GI during the course of postoperative therapy
- To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection
- To evaluate surgery-related adverse events occurring up to 90 days after surgery, and chemo-related adverse events occurring up to 30 days after the last dose of chemotherapy
Outcome Measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX/FOLFIRI +/- bevacizumab or panitumumab/cetuximab) from 07/01/2021 - 12/31/2023
- •Must receive ≥ 4 cycles of preoperative chemotherapy
排除标准
- •Patients with primary colorectal tumor that will remain in situ
- •Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori
- •Unwilling/unable to undergo blood draws for ctDNA, patient or provider-determined
- •Other active malignancies requiring treatment
- •Women who are pregnant
研究组 & 干预措施
ctDNA (High Risk)
Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)
干预措施: Irinotecan (Drug)
ctDNA (High Risk)
Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)
干预措施: Capecitabine (Drug)
ctDNA (High Risk)
Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)
干预措施: 5-FLUOROURACIL (Drug)
ctDNA (High Risk)
Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)
干预措施: Oxaliplatin (Drug)
ctDNA (Low Risk)
Will receive less intense chemotherapy, such as capecitabine or 5-fluorouracil.
干预措施: Capecitabine (Drug)
ctDNA (Low Risk)
Will receive less intense chemotherapy, such as capecitabine or 5-fluorouracil.
干预措施: Leucovorin (Drug)
ctDNA (High Risk)
Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)
干预措施: Leucovorin (Drug)
ctDNA (High Risk)
Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)
干预措施: Bevacizumab (Drug)
结局指标
主要结局
To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点