Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT06385418
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluorouracil Treatment Via Colon for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (according to RECIST1.1, investigator assessment)', 'timeFrame': 'One, three, and six months (or until conversion to surgery) after the initial treatment', 'description': 'Objective response rate (ORR) is defined as complete response (CR) and partial response (PR) proportion of participants.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'One, three, and six months (or until conversion to surgery) after the initial treatment', 'description': '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.'}, {'measure': 'Overall survival', 'timeFrame': 'Every 3 months up to 24 months after the end of treatment', 'description': 'Overall survival (OS) is defined as the time from the first initiation of the study regimen to death from any cause time.'}, {'measure': 'Disease control rate (according to RECIST1.1, investigator assessment)', 'timeFrame': 'One, three, and six months (or before conversion to surgery) after the initial treatment', 'description': 'Disease control rate (DCR) is defined as the proportion of participants with complete response (CR), partial response (PR) and stable disease (SD) × 100%.'}, {'measure': 'Drop period to ensure operation resection', 'timeFrame': 'Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment', 'description': '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.'}, {'measure': 'Converted resection rate', 'timeFrame': 'Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment', 'description': 'Surgical conversion rate, defined as the proportion of participants who achieved gross complete resection after 4-6 courses of study induction therapy.'}, {'measure': 'Actual R0 resection rate', 'timeFrame': 'Time from the first treatment to 4-6 cycles (each cycle is 28 days) of treatment', 'description': 'Actual R0 resection rate is defined as the proportion of participants who achieved R0 surgical resection after 4-6 courses of study induction therapy.'}, {'measure': 'The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0', 'timeFrame': 'Throughout the treatment period and continuing for an additional 6 months after the treatment concludes, an average of 1 year', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorouracil', 'Transendoscopic enteral tubing', 'Thermosensitive hydrogel', 'Colorectal Cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '18155370', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12724731', 'type': 'BACKGROUND', 'citation': 'Longley 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.'}, {'pmid': '8996131', 'type': 'BACKGROUND', 'citation': 'Liu 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.'}, {'pmid': '8726182', 'type': 'BACKGROUND', 'citation': 'Galandiuk 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.'}, {'pmid': '36803264', 'type': 'BACKGROUND', 'citation': 'Kulkarni 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.'}, {'pmid': '32417265', 'type': 'BACKGROUND', 'citation': 'Zarrintaj 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.'}, {'pmid': '33222768', 'type': 'BACKGROUND', 'citation': 'Al 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.'}, {'pmid': '33727143', 'type': 'BACKGROUND', 'citation': 'Seguin 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.'}, {'pmid': '38321613', 'type': 'BACKGROUND', 'citation': 'Zhang 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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chinese individuals aged 18 to 75 years, both male and female;\n2. Histologically confirmed diagnosis of colorectal cancer with measurable primary lesion according to RECIST 1.1;\n3. ECOG performance status ≤2;\n4. Expected survival of more than 3 months;\n5. Multidisciplinary team consensus that the patient is suitable for adding local chemotherapy to the established tumor treatment regimen;\n6. 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%;\n7. 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;\n8. Suitable physical condition and personal willingness to undergo colonic transendoscopic enteral tubing;\n9. Willingness to cooperate with physicians, and agree to regular follow-up visits and examinations as recommended after completion of treatment;\n10. Agreement to specimen collection and voluntary signing of a written informed consent form.\n\nExclusion Criteria:\n\n1. 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;\n2. Active severe clinical infections (≥ Grade 2 according to NCI-CTCAE version 5.0), including fungal, viral, or tuberculosis infections within the gastrointestinal tract;\n3. 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;\n4. History of immunodeficiency or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n5. 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;\n6. Presence of other serious diseases that would render the subject ineligible for enrollment as determined by the investigator;\n7. Breastfeeding women;\n8. Known allergy or intolerance to the investigational drug or its excipients;\n9. Participation in another drug clinical trial within the past four weeks;\n10. Lack of legal capacity or restricted legal capacity.'}, 'identificationModule': {'nctId': 'NCT06385418', 'briefTitle': 'Fluorouracil Treatment Via Colon for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Fluorouracil Treatment Via Colon for Colorectal Cancer: an Exploratory Study', 'orgStudyIdInfo': {'id': 'WST-CRC-202404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '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.', 'interventionNames': ['Drug: Colonic local administration of fluorouracil with enhanced adhesion']}], 'interventions': [{'name': 'Colonic local administration of fluorouracil with enhanced adhesion', 'type': 'DRUG', '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.', 'armGroupLabels': ['Colonic local administration of fluorouracil with enhanced adhesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faming Zhang, MD, PhD', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Faming Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '86-025-58509883'}], 'overallOfficials': [{'name': 'Faming Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Microbiota Medicine & Medical Center for Digestive Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Faming Zhang', 'investigatorAffiliation': 'The Second Hospital of Nanjing Medical University'}}}}