Fluorouracil Treatment Via Colon for Colorectal Cancer

NCT ID: NCT06385418

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2029-05-01

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colonic local administration of fluorouracil with enhanced adhesion

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.

Group Type: EXPERIMENTAL

Colonic local administration of fluorouracil with enhanced adhesion

Intervention Type: DRUG

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.

Interventions

Colonic local administration of fluorouracil with enhanced adhesion

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Microbiota Medicine & Medical Center for Digestive Diseases

Locations

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Faming Zhang, MD, PhD

Role: CONTACT

fzhang@njmu.edu.cn

86-025-58509883

Facility Contacts

Faming Zhang, MD, PhD

Role: primary

References

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Other Identifiers

WST-CRC-202404

Identifier Type: -

Identifier Source: org_study_id