Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 11:07 AM
Study NCT ID:
NCT07391618
Status:
RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 583}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'up to 3 years'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to 3 years'}, {'measure': 'DCR', 'timeFrame': 'up to 3 years'}, {'measure': 'DoR', 'timeFrame': 'up to 3 years'}, {'measure': 'OS', 'timeFrame': 'up to 3 years'}, {'measure': 'Adverse Event', 'timeFrame': 'Thirty days after the last treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['levozolinate'], 'conditions': ['Advanced Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer', 'detailedDescription': 'To observe and evaluate the efficacy and safety of simultaneous infusion of levofolinate for injection and 5-FU in the first-line treatment of advanced colorectal cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subjects voluntarily joined this study and signed the informed consent form.\n2. Age: 18 to 75 years old, gender not limited;\n3. ECOG PS score: 0-2 points\n4. Patients with unresectable or metastatic colorectal cancer confirmed by histology or cytology, where the primary tumor location and the status of RAS and BRAF are known;\n5. No previous treatment for unresectable or metastatic lesions has been received;\n6. There is at least one measurable lesion in accordance with the RECIST 1.1 standard;\n7. In the pre-treatment examination indicators, there was no serious hematopoietic function abnormality, and the functions of the heart, lungs, liver and kidneys were basically normal.\n\n 1. Hemoglobin (Hb) ≥70 g/L;\n 2. White blood cell count (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥1.5×109/L;\n 3. Platelet count (PLT) ≥100×109/L;\n 4. Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level ≤2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level ≤1.5 times the upper limit of the normal value (ULN). Total bilirubin (TBIL) ≤1.5 times the upper limit of the normal value (ULN).\n8. The expected survival period is more than three months.\n\nExclusion Criteria:\n\n1. Those who have been confirmed to be allergic to the test drug and/or its excipients;\n2. Those with contraindications to chemotherapy;\n3. Colorectal cancer patients with MSI-H or dMMR;\n4. Pregnant or lactating women;\n5. There is a history of other malignant tumors in the past;\n6. Those with systemic internal diseases and mental disorders who are not suitable for chemotherapy;\n7. Patients who were determined by the researchers to be unsuitable for inclusion in this study.'}, 'identificationModule': {'nctId': 'NCT07391618', 'briefTitle': 'Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'A Study to Evaluate the Efficacy and Safety of a First-line Treatment for Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU', 'orgStudyIdInfo': {'id': 'HL-ZY-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arm1', 'description': 'For patients with wild-type RAS and BRAF and the primary lesion located in the left colorectum, the mFOLFOX6 or FOLFIRI regimens with simultaneous infusion of levofolinic acid and 5-FU for injection were received. Whether to combine cetuximab was determined by the researchers', 'interventionNames': ['Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy)']}, {'type': 'EXPERIMENTAL', 'label': 'arm2', 'description': 'For patients with both RAS and BRAF wild-type and with the primary lesion located in the right colorectal and/or RAS or BRAF mutant type, the mFOLFOX6 or FOLFIRI regimen with simultaneous infusion of levofolinic acid and 5-FU for injection, whether to combine bevacizumab, was determined by the researchers', 'interventionNames': ['Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy)']}], 'interventions': [{'name': 'mFOLFOX/FOLFIRI ( Standard Chemotherapy)', 'type': 'DRUG', 'description': 'mFOLFOX6: Oxaliplatin 85mg/m², intravenous infusion for 2 hours, day 1; 5-FU 400mg/m² injection, d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs. FOLFIRI: Irinotecan 180mg/m², intravenous infusion for 30 to 90 minutes on day 1; 5-FU 400mg/m² injection d1; Levofolic acid for injection at 200mg/m² and 5-FU at 2400mg/m² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs.', 'armGroupLabels': ['arm1', 'arm2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanghai Dai', 'role': 'CONTACT', 'email': 'daigh301@vip.sina.com', 'phone': '+861066947252'}], 'facility': 'Chinese PLA General Hospital, Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Guanghai Dai', 'role': 'CONTACT', 'email': 'daigh301@vip.sina.com', 'phone': '+861066947252'}, {'name': 'miaomiao Gou', 'role': 'CONTACT', 'email': 'daigh301@vip.sina.com'}], 'overallOfficials': [{'name': 'Guanghai Dai', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dai, Guanghai', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}