Local administration of fluorouracil for colorectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a novel method for administering fluorouracil (5-FU) to patients with colorectal cancer using a thermosensitive hydrogel and colonic transendoscopic enteral tubing. The approach aims to enhance the adhesion of the drug within the colon, potentially improving its efficacy and safety compared to traditional administration methods. The study will assess the feasibility, safety, and effectiveness of this integrated treatment strategy in a Phase 2 setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Chinese individuals aged 18 to 75 years, both male and female;
2. Histologically confirmed diagnosis of colorectal cancer with measurable primary lesion according to RECIST 1.1;
3. ECOG performance status ≤2;
4. Expected survival of more than 3 months;
5. Multidisciplinary team consensus that the patient is suitable for adding local chemotherapy to the established tumor treatment regimen;
6. 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%;
7. 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;
8. Suitable physical condition and personal willingness to undergo colonic transendoscopic enteral tubing;
9. Willingness to cooperate with physicians, and agree to regular follow-up visits and examinations as recommended after completion of treatment;
10. Agreement to specimen collection and voluntary signing of a written informed consent form.

Exclusion Criteria:

1. 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;
2. Active severe clinical infections (≥ Grade 2 according to NCI-CTCAE version 5.0), including fungal, viral, or tuberculosis infections within the gastrointestinal tract;
3. 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;
4. History of immunodeficiency or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
5. 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;
6. Presence of other serious diseases that would render the subject ineligible for enrollment as determined by the investigator;
7. Breastfeeding women;
8. Known allergy or intolerance to the investigational drug or its excipients;
9. Participation in another drug clinical trial within the past four weeks;
10. Lack of legal capacity or restricted legal capacity.

Where it's running

• The Second Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Faming Zhang, MD, PhD — Department of Microbiota Medicine & Medical Center for Digestive Diseases
• Study coordinator: Faming Zhang, MD, PhD
• Email: fzhang@njmu.edu.cn
• Phone: 86-025-58509883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.