Colorectal CancerPhase 2NCT06385418
Fluorouracil Treatment Via Colon for Colorectal Cancer
A Phase 2 study testing Colonic local administration of fluorouracil with enhanced adhesion in people with Colorectal Cancer, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonic local administration of fluorouracil with enhanced adhesion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2024to 1 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Multidisciplinary team consensus that the patient is suitable for adding local chemotherapy to the established tumor treatment regimen;
- 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%;
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- 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;
- Suitable physical condition and personal willingness to undergo colonic transendoscopic enteral tubing;
- Willingness to cooperate with physicians, and agree to regular follow-up visits and examinations as recommended after completion of treatment;
- Agreement to specimen collection and voluntary signing of a written informed consent form.
Who cannot join
- 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;
- 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;
- Presence of other serious diseases that would render the subject ineligible for enrollment as determined by the investigator;
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- Breastfeeding women;
- Known allergy or intolerance to the investigational drug or its excipients;
- Participation in another drug clinical trial within the past four weeks;
- Lack of legal capacity or restricted legal capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD, PhD
About this study
Official title: Fluorouracil Treatment Via Colon for Colorectal Cancer: an Exploratory Study
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
- Being tested
- Colonic local administration of fluorouracil with enhanced adhesion
- Keywords
- Fluorouracil, Transendoscopic enteral tubing, Thermosensitive hydrogel, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic local administration of fluorouracil with enhanced adhesionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Colonic local administration of fluorouracil with enhanced adhesion | Experimental | 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. Receives: Drug: Colonic local administration of fluorouracil with enhanced adhesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One, three, and six months (or until conversion to surgery) after the initial treatment
Secondary outcomes (7)
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.
Measured: One, three, and six months (or until conversion to surgery) after the initial treatment
Overall survival
Overall survival (OS) is defined as the time from the first initiation of the study regimen to death from any cause time.
Measured: Every 3 months up to 24 months after the end of treatment
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%.
Measured: One, three, and six months (or before conversion to surgery) after the initial treatment
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.
Measured: Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment
Converted resection rate
Surgical conversion rate, defined as the proportion of participants who achieved gross complete resection after 4-6 courses of study induction therapy.
Measured: Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment
Actual R0 resection rate
Actual R0 resection rate is defined as the proportion of participants who achieved R0 surgical resection after 4-6 courses of study induction therapy.
Measured: Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment.
Measured: Throughout the treatment period and continuing for an additional 6 months after the treatment concludes, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start16 May 2024
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, MD, PhD, Principal investigator, Department of Microbiota Medicine & Medical Center for Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385418
- Sponsor's protocol ID
- WST-CRC-202404
- Status last verified
- Jun 2024
- First submitted
- 17 Apr 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun W, Zhang N, Li A, Zou W, Xu W. Preparation and evaluation of N(3)-O-toluyl-fluorouracil-loaded liposomes. Int J Pharm. 2008 Apr 2;353(1-2):243-50. doi: 10.1016/j.ijpharm.2007.11.017. Epub 2007 Nov 17.
PubMed 18155370Longley DB, Harkin DP, Johnston PG. 5-fluorouracil: mechanisms of action and clinical strategies. Nat Rev Cancer. 2003 May;3(5):330-8. doi: 10.1038/nrc1074.
PubMed 12724731Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997 Jan;15(1):110-5. doi: 10.1200/JCO.1997.15.1.110.
PubMed 8996131Galandiuk S, Wrightson W, Marr L, Myers S, LaRocca RV. Suppository delivery of 5-fluorouracil in rectal cancer. Ann Surg Oncol. 1996 May;3(3):270-6. doi: 10.1007/BF02306282.
PubMed 8726182Kulkarni R, Fanse S, Burgess DJ. Mucoadhesive drug delivery systems: a promising noninvasive approach to bioavailability enhancement. Part II: formulation considerations. Expert Opin Drug Deliv. 2023 Mar;20(3):413-434. doi: 10.1080/17425247.2023.2181332. Epub 2023 Feb 22.
PubMed 36803264Zarrintaj P, Ramsey JD, Samadi A, Atoufi Z, Yazdi MK, Ganjali MR, Amirabad LM, Zangene E, Farokhi M, Formela K, Saeb MR, Mozafari M, Thomas S. Poloxamer: A versatile tri-block copolymer for biomedical applications. Acta Biomater. 2020 Jul 1;110:37-67. doi: 10.1016/j.actbio.2020.04.028. Epub 2020 May 15.
PubMed 32417265Al Sabbagh C, Seguin J, Agapova E, Kramerich D, Boudy V, Mignet N. Thermosensitive hydrogels for local delivery of 5-fluorouracil as neoadjuvant or adjuvant therapy in colorectal cancer. Eur J Pharm Biopharm. 2020 Dec;157:154-164. doi: 10.1016/j.ejpb.2020.10.011. Epub 2020 Oct 22.
PubMed 33222768Seguin J, Pimpie C, Roy P, Al Sabbagh C, Pocard M, Mignet N, Boudy V. Combination of tumor cell anti-adhesion and anti-tumor effect to prevent recurrence after cytoreductive surgery in a mice model. Eur J Pharm Biopharm. 2021 Dec;169:37-43. doi: 10.1016/j.ejpb.2021.01.020. Epub 2021 Mar 14.
PubMed 33727143Zhang F, Lu G, Wang X, Wu L, Li R, Nie Y. Concept, breakthrough, and future of colonic transendoscopic enteral tubing. Chin Med J (Engl). 2024 Mar 20;137(6):633-635. doi: 10.1097/CM9.0000000000003020. Epub 2024 Feb 7. No abstract available.
PubMed 38321613
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorouracil Treatment Via Colon for Colorectal Cancer: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06385418
- Acronym / sponsor ID
- WST-CRC-202404
- Conditions
- Colorectal Cancer
- Keywords
- Fluorouracil, Transendoscopic enteral tubing, Thermosensitive hydrogel, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic local administration of fluorouracil with enhanced adhesion | Experimental | Drug: Colonic local administration of fluorouracil with enhanced adhesionFluorouracil 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- Multidisciplinary team consensus that the patient is suitable for adding local chemotherapy to the established tumor treatment regimen;
Key exclusion criteria (10 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic local administration of fluorouracil with enhanced adhesionFluorouracil 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. | Drug | Colonic local administration of fluorouracil with enhanced adhesion |
Primary outcome
Objective response rate (according to RECIST1.1, investigator assessment)
Time frame: One, three, and six months (or until conversion to surgery) after the initial treatment
Objective response rate (ORR) is defined as complete response (CR) and partial response (PR) proportion of participants.
7 secondary outcomes
Progression-free survival
Time frame: One, three, and six months (or until conversion to surgery) after the initial treatment
Overall survival
Time frame: Every 3 months up to 24 months after the end of treatment
Disease control rate (according to RECIST1.1, investigator assessment)
Time frame: One, three, and six months (or before conversion to surgery) after the initial treatment
Drop period to ensure operation resection
Time frame: Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment
Converted resection rate
Time frame: Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment
Actual R0 resection rate
Time frame: Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time frame: Throughout the treatment period and continuing for an additional 6 months after the treatment concludes, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 18155370Sun W, Zhang N, Li A, Zou W, Xu W. Preparation and evaluation of N(3)-O-toluyl-fluorouracil-loaded liposomes. Int J Pharm. 2008 Apr 2;353(1-2):243-50. doi: 10.1016/j.ijpharm.2007.11.017. Epub 2007 Nov 17.
- Background: PubMed 12724731Longley DB, Harkin DP, Johnston PG. 5-fluorouracil: mechanisms of action and clinical strategies. Nat Rev Cancer. 2003 May;3(5):330-8. doi: 10.1038/nrc1074.
- Background: PubMed 8996131Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997 Jan;15(1):110-5. doi: 10.1200/JCO.1997.15.1.110.
- Background: PubMed 8726182Galandiuk S, Wrightson W, Marr L, Myers S, LaRocca RV. Suppository delivery of 5-fluorouracil in rectal cancer. Ann Surg Oncol. 1996 May;3(3):270-6. doi: 10.1007/BF02306282.
- Background: PubMed 36803264Kulkarni R, Fanse S, Burgess DJ. Mucoadhesive drug delivery systems: a promising noninvasive approach to bioavailability enhancement. Part II: formulation considerations. Expert Opin Drug Deliv. 2023 Mar;20(3):413-434. doi: 10.1080/17425247.2023.2181332. Epub 2023 Feb 22.
- Background: PubMed 32417265Zarrintaj P, Ramsey JD, Samadi A, Atoufi Z, Yazdi MK, Ganjali MR, Amirabad LM, Zangene E, Farokhi M, Formela K, Saeb MR, Mozafari M, Thomas S. Poloxamer: A versatile tri-block copolymer for biomedical applications. Acta Biomater. 2020 Jul 1;110:37-67. doi: 10.1016/j.actbio.2020.04.028. Epub 2020 May 15.
- Background: PubMed 33222768Al Sabbagh C, Seguin J, Agapova E, Kramerich D, Boudy V, Mignet N. Thermosensitive hydrogels for local delivery of 5-fluorouracil as neoadjuvant or adjuvant therapy in colorectal cancer. Eur J Pharm Biopharm. 2020 Dec;157:154-164. doi: 10.1016/j.ejpb.2020.10.011. Epub 2020 Oct 22.
- Background: PubMed 33727143Seguin J, Pimpie C, Roy P, Al Sabbagh C, Pocard M, Mignet N, Boudy V. Combination of tumor cell anti-adhesion and anti-tumor effect to prevent recurrence after cytoreductive surgery in a mice model. Eur J Pharm Biopharm. 2021 Dec;169:37-43. doi: 10.1016/j.ejpb.2021.01.020. Epub 2021 Mar 14.
- Background: PubMed 38321613Zhang F, Lu G, Wang X, Wu L, Li R, Nie Y. Concept, breakthrough, and future of colonic transendoscopic enteral tubing. Chin Med J (Engl). 2024 Mar 20;137(6):633-635. doi: 10.1097/CM9.0000000000003020. Epub 2024 Feb 7. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faming Zhang, MD, PhD principal investigator
Department of Microbiota Medicine & Medical Center for Digestive Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colonic local administration of fluorouracil with enhanced adhesion in people with Colorectal Cancer, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, MD, PhD (86-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (according to RECIST1.1, investigator assessment) (time frame: One, three, and six months (or until conversion to surgery) after the initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06385418, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.