NCT06385418招募中2 期
Fluorouracil Treatment Via Colon for Colorectal Cancer: an Exploratory Study
The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate (according to RECIST1.1, investigator assessment)
研究概览
简要总结
Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese individuals aged 18 to 75 years, both male and female;
- •Histologically confirmed diagnosis of colorectal cancer with measurable primary lesion according to RECIST 1.1;
- •ECOG performance status ≤2;
- •Expected survival of more than 3 months;
- •Multidisciplinary team consensus that the patient is suitable for adding local chemotherapy to the established tumor treatment regimen;
- •Adequate organ function meeting the following criteria: (1) Absolute neutrophil count ≥1.5 × 10^9/L, platelets ≥100 × 10^9/L, hemoglobin ≥90 g/L; (2) Total bilirubin ≤1.5 times the upper limit of normal (patients with biliary drainage via retrograde techniques included); ALT and AST ≤5 times the upper limit of normal, and for patients with liver metastases, serum total bilirubin less than or equal to 3 times the upper limit of the normal reference range; (3) Creatinine <120 μmol/L, or MDRD estimated glomerular filtration rate >60 mL/min; (4) Doppler echocardiography assessment: Left ventricular ejection fraction (LVEF) ≥50%;
- •Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment, and sexually active men or women agree to use appropriate contraception during the trial and for 8 weeks after the last dose of investigational drug;
- •Suitable physical condition and personal willingness to undergo colonic transendoscopic enteral tubing;
- •Willingness to cooperate with physicians, and agree to regular follow-up visits and examinations as recommended after completion of treatment;
- •Agreement to specimen collection and voluntary signing of a written informed consent form.
排除标准
- •Uncontrolled cardiovascular diseases, such as congestive heart failure (NYHA III-IV), coronary artery disease, cardiomyopathy, arrhythmias, or hemodynamic instability at enrollment, with a risk of significant events during the treatment period;
- •Active severe clinical infections (≥ Grade 2 according to NCI-CTCAE version 5.0), including fungal, viral, or tuberculosis infections within the gastrointestinal tract;
- •Coagulation abnormalities with bleeding tendencies (who do not meet the criteria of having a normal INR without the use of anticoagulants within 14 days prior to enrollment). Participants receiving anticoagulants or vitamin K antagonists such as warfarin or heparin are excluded unless their international normalized ratio (INR) is ≤1.5, with allowance for low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylaxis;
- •History of immunodeficiency or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- •Known progressive or actively treated other malignancies requiring intervention, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ;
- •Presence of other serious diseases that would render the subject ineligible for enrollment as determined by the investigator;
- •Breastfeeding women;
- •Known allergy or intolerance to the investigational drug or its excipients;
- •Participation in another drug clinical trial within the past four weeks;
- •Lack of legal capacity or restricted legal capacity.
研究组 & 干预措施
Colonic local administration of fluorouracil with enhanced adhesion
Experimental
Fluorouracil is administered via the colon as an injectable solution at a dose of 500 mg per day for 6 days, along with poloxamer 407 and poloxamer 188 used as thermosensitive hydrogel to enhance adhesion.
干预措施: Colonic local administration of fluorouracil with enhanced adhesion (Drug)
结局指标
主要结局
Objective response rate (according to RECIST1.1, investigator assessment)
时间窗: One, three, and six months (or until conversion to surgery) after the initial treatment
Objective response rate (ORR) is defined as complete response (CR) and partial response (PR) proportion of participants.
次要结局
- Converted resection rate(Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment)
- Actual R0 resection rate(Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment)
- The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0(Throughout the treatment period and continuing for an additional 6 months after the treatment concludes, an average of 1 year)
- Progression-free survival(One, three, and six months (or until conversion to surgery) after the initial treatment)
- Overall survival(Every 3 months up to 24 months after the end of treatment)
- Disease control rate (according to RECIST1.1, investigator assessment)(One, three, and six months (or before conversion to surgery) after the initial treatment)
- Drop period to ensure operation resection(Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment)
研究者
Faming Zhang
Vice President
The Second Hospital of Nanjing Medical University
研究点 (1)
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