NCT04457297已完成3 期
A Randomized, Double-Blind, Phase III Study Comparing FTD/TPI Therapy Versus Placebo in Patients Who Are Positive for Blood Circulating Tumor DNA After Curative Resection of Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 39
- 主要终点
- Disease-free survival 1 (DFS1)
研究概览
简要总结
This trial is a randomized, double-blind, multinational Phase III study to evaluate the efficacy and safety of preemptive treatment with FTD/TPI compared with administration of placebo as follow-up, which is the standard of care, in patients who underwent curative resection of colorectal cancer and then tested positive for ctDNA.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been histopathologically diagnosed with colorectal adenocarcinoma
- •Patients who have undergone radical curative resection of the primary and metastatic tumors
- •Patients with colon or rectal cancer of Stage III based on final findings (T any N1/2 M0) (UICC TNM Classification, 8th Edition) who have a past history of standard postoperative chemotherapy
- •Patients who tested positive for ctDNA using SignateraTM by an analysis of the latest blood samples collected within 3 months prior to enrollment
- •Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans, etc.
- •Patients who are capable of oral ingestion
- •Patients aged 20 years or older at the time of informed consent
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •Patients who have no severe disorder in major organs (such as the bone marrow, heart, lungs, liver, and kidneys) and meet the following criteria (Data obtained most recently and within 14 days of the date of enrollment will be used for enrollment. Data obtained 2 weeks before the date of enrollment, on the same day of the week as the enrollment date, may be used for enrollment.)
- •Neutrophil count ≥ 1,500/mm3
- •Platelet count ≥ 100,000/mm3
- •Hemoglobin ≥ 8.0 g/dL
- •Serum creatinine ≤ 1.5 mg/dL
- •Total bilirubin ≤ 1.5 mg/dL
- •ALT and AST ≤ 100 U/L
- •Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- •Patients who voluntarily gave written consent to participate in the trial after receiving a thorough explanation of the trial before enrolling in the trial
排除标准
- •Patients with a history of treatment with FTD/TPI
- •Patients with a history of treatment with 2 or more regimens of postoperative adjuvant chemotherapy (Preoperative chemotherapy will not be counted as a regimen.)
- •Patients with a past history of a malignant tumor
- •Patients with a local or systemic active infection requiring intervention
- •Patients who are positive for HBs antigen or positive for HCV antibody
- •Patients who are positive for HIV antibody (Patients who have not been tested for HIV antibody may be enrolled.)
- •Patients with poorly controlled infections or diabetes
- •Patients with a past history of interstitial lung diseases (such as interstitial pneumonia and pulmonary fibrosis) requiring treatment or extensive findings of these diseases on CT
- •Patients with a serious complication
- •Patients who have been receiving systemic administration (oral or intravenous) of steroids (for 2 weeks or more at a dose of the equivalent of ≥ 10 mg/day of prednisolone)
- •Patients for whom enrollment in the trial is difficult because of clinically problematic psychiatric disorders
- •Pregnant or lactating women
- •Patients with reproductive potential who do not wish to use adequate contraceptive measures during the period of participation in the trial and during the contraception period
- •Patients who are judged by the attending physician to be ineligible for enrollment in the trial for other reasons
研究组 & 干预措施
trifluridine and tipiracil
Experimental
干预措施: trifluridine and tipiracil (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Disease-free survival 1 (DFS1)
时间窗: Up to 3 years
The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a secondary colorectal cancer lesion other than a relapse and death from any cause.
次要结局
- Rate of Conversion to Negative ctDNA(Up to 2 years)
- Overall Survival (OS)(Up to 3 years)
- Disease-free survival 2 (DFS2)(Up to 3 years)
- Incidence of Adverse Events(Up to 3 years)
- Treatment Completion Rate(Up to 3 years)
研究者
Takayuki Yoshino
MD., PhD Head of Department of Gastroenterology and Gastrointestinal Oncology
National Cancer Center Hospital East
研究点 (39)
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