Fluorouracil Treatment Via Colon for Colorectal Cancer
ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chinese individuals aged 18 to 75 years, both male and female;
Histologically confirmed diagnosis of colorectal cancer with measurable primary lesion according to RECIST 1.1;
ECOG performance status ≤2;
Expected survival of more than 3 months;
Disqualifiers
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;
Active severe clinical infections (≥ Grade 2 according to NCI-CTCAE version 5.0), including fungal, viral, or tuberculosis infections within the gastrointestinal tract;
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;
History of immunodeficiency or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
Trial design
Design model
Single group
Treatments tested in this trial
Colonic local administration of fluorouracil with enhanced adhesion
DrugFluorouracil 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Colonic local administration of fluorouracil with enhanced adhesionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (according to RECIST1.1, investigator assessment)
Objective response rate (ORR) is defined as complete response (CR) and partial response (PR) proportion of participants.
Time frame
One, three, and six months (or until conversion to surgery) after the initial treatmentSecondary outcomes
1
Progression-free survival
Progression-free survival (PFS) is defined as the time from the first initiation of study regimen treatment to the first imaging disease progression or the time of death, whichever occurs first.
Time frame
One, three, and six months (or until conversion to surgery) after the initial treatment2
Overall survival
Overall survival (OS) is defined as the time from the first initiation of the study regimen to death from any cause time.
Time frame
Every 3 months up to 24 months after the end of treatment3
Disease control rate (according to RECIST1.1, investigator assessment)
Disease control rate (DCR) is defined as the proportion of participants with complete response (CR), partial response (PR) and stable disease (SD) × 100%.
Time frame
One, three, and six months (or before conversion to surgery) after the initial treatment4
Drop period to ensure operation resection
Drop period to ensure operation resection is defined as the proportion of participants whose tumors shrink following study induction therapy, thereby enhancing the safety and feasibility of surgical removal.
Time frame
Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatmentSponsors and contacts
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Source ClinicalTrials.gov