Fluorouracil Treatment Via Colon for Colorectal Cancer

Trial Title: Fluorouracil Treatment Via Colon for Colorectal Cancer

NCT ID: NCT06385418

Condition: Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms
Fluorouracil

Conditions: Keywords:
Fluorouracil
Transendoscopic enteral tubing
Thermosensitive hydrogel
Colorectal Cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Colonic local administration of fluorouracil with enhanced adhesion
Description: 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.
Arm group label: Colonic local administration of fluorouracil with enhanced adhesion

Summary: 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Second Affiliated Hospital of Nanjing Medical University

Address:
City: Nanjing
Zip: 210011
Country: China

Status: Recruiting

Contact:
Last name: Faming Zhang, MD, PhD

Start date: May 16, 2024

Completion date: May 1, 2029

Lead sponsor:
Agency: The Second Hospital of Nanjing Medical University
Agency class: Other

Source: The Second Hospital of Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06385418