Actively Recruiting
Fluorouracil Treatment Via Colon for Colorectal Cancer
Led by The Second Hospital of Nanjing Medical University · Updated on 2024-06-26
40
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Fluorouracil Treatment Via Colon for Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese individuals aged 18 to 75 years, male or female
- Histologically confirmed colorectal cancer with measurable primary lesion according to RECIST 1.1
- ECOG performance status of 2 or less
- Expected survival longer than 3 months
- Multidisciplinary team agreement that adding local chemotherapy is appropriate
- Adequate organ function including specific blood counts, liver and kidney function, and heart function (LVEF 50%)
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment
- Sexually active participants agree to use effective contraception during the trial and for 8 weeks after last dose
- Suitable physical condition and willingness to undergo colonic transendoscopic enteral tubing
- Willingness to cooperate with physicians and attend regular follow-up visits
- Agreement to specimen collection and signing informed consent form
You will not qualify if you...
- Uncontrolled cardiovascular diseases with risk of serious events during treatment
- Active severe infections in the gastrointestinal tract
- Coagulation problems with bleeding tendencies or inadequate anticoagulant control
- History of immunodeficiency or organ transplantation
- Other progressive or actively treated cancers requiring intervention, except certain skin or cervical cancers
- Other serious diseases making participation unsafe
- Breastfeeding women
- Known allergy or intolerance to fluorouracil or its components
- Participation in another drug trial within the past four weeks
- Lack of full legal capacity or restricted legal capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Actively Recruiting
Research Team
F
Faming Zhang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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