Local administration of fluorouracil for colorectal cancer treatment

Fluorouracil Treatment Via Colon for Colorectal Cancer: an Exploratory Study

This study is testing a new way to deliver a cancer drug directly to the colon for people with colorectal cancer to see if it works better and is safer than the usual methods.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second Hospital of Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06385418 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include Chinese individuals aged 18 to 75 with histologically confirmed colorectal cancer and a measurable primary lesion.

Not a fit: Patients with severe organ dysfunction or those not suitable for local chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer method for delivering chemotherapy to colorectal cancer patients.

How similar studies have performed: While the use of thermosensitive hydrogels in drug delivery is promising, this specific approach has not been widely tested in previous studies.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• 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

Conditions Colorectal Cancer; Fluorouracil; Transendoscopic enteral tubing; Thermosensitive hydrogel