Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-27 @ 7:15 PM
Study NCT ID:
NCT05575635
Status:
UNKNOWN
Last Update Posted:
2022-10-12
First Post:
2022-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591844', 'term': 'HMPL-013'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-08', 'studyFirstSubmitDate': '2022-10-08', 'studyFirstSubmitQcDate': '2022-10-08', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCR', 'timeFrame': 'about 2 months', 'description': 'pathological complete response rate assessed by the investigator'}], 'secondaryOutcomes': [{'measure': 'MPR', 'timeFrame': 'about 2 months', 'description': 'major pathological response rate assessed by the investigator'}, {'measure': 'ORR', 'timeFrame': 'about 2 months', 'description': 'objective response rate assessed by the investigator'}, {'measure': 'R0 resection rate', 'timeFrame': 'about 2 months', 'description': 'R0 resection rate'}, {'measure': 'DFS', 'timeFrame': 'about 3 years', 'description': 'DFS (Disease-free survival) will be calculated from the date of first administration of study drug to the date of recurrence or death by any reason.'}, {'measure': 'OS', 'timeFrame': 'about 5 years', 'description': 'OS will be calculated from the date of first administration of study drug to the date of death by any reason.'}, {'measure': 'TRAEs', 'timeFrame': 'about 6 months', 'description': 'treatment-related adverse events by CTCAE v5.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neoadjuvant', 'peri-operative'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the efficacy and safety of fruquintinib combined with mFOLFOX6 + synchronous radiotherapy as neoadjuvant therapy in middle and low locally advanced rectal cancer patients with no previous anti-tumor treatment.', 'detailedDescription': 'The study aims to evaluate the efficacy and safety of fruquintinib combined with mFOLFOX6 + synchronous radiotherapy as neoadjuvant therapy in middle and low locally advanced rectal cancer patients with no previous anti-tumor treatment. Approximately 40 patients will be enrolled and undergo combination neoadjuvant therapy, followed by TME and mFOLFOX6 adjuvant therapy, peri-operative treatment will last for 6 months. The primary endpoint is pCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed rectal adenocarcinoma, classified as stage II (T3-4N0) or stage III (T1-4N1-2) by MRI and CT;\n* Middle and low rectal cancer with the lower pole of the tumor less than 12 cm from the anal margin;\n* The multidisciplinary cancer committee recommended neoadjuvant radiotherapy, chemotherapy and surgery;\n* ECOG PS 0-1;\n* Expected survival ≥ 2 years;\n* Have not received any anti-tumor treatment;\n* Have at least one measurable lesion;\n* Sufficient organs and bone marrow functions;\n* Women of childbearing age need to take effective contraceptive measures;\n\nExclusion Criteria:\n\n* Patients with surgical contraindication;\n* Patients with familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active Crohn's disease or active ulcerative colitis;\n* Other malignant tumors found within 5 years before enrollment, except skin basal cell or squamous cell carcinoma, or cervical carcinoma in situ after radical surgery;\n* Serious cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurred within 6 months before enrollment;\n* International normalized ratio (INR)\\>1.5 or partially activated prothrombin time (APTT)\\>1.5 × ULN；\n* Investigators judged clinically significant electrolyte abnormalities;\n* Hypertension that could not be controlled by drugs before enrollment, which was defined as: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg;\n* Poorly controlled diabetes mellitus before enrollment (fasting glucose concentration ≥ CTCAE level 2 after regular treatment);\n* Active ulcer of stomach and duodenum, ulcerative colitis and other digestive tract diseases before enrollment, or other conditions that may cause gastrointestinal bleeding and perforation judged by the researcher;\n* Serious active bleeding, hemoptysis (\\>5 mL fresh blood within 4 weeks) or thromboembolism (including stroke and/or transient ischemic attack) occurred within 12 months before enrollment;\n* Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure New York Heart Association (NYHA) grade\\>2; Ventricular arrhythmias requiring medication; LVEF\\<50%;\n* Active or uncontrollable serious infection (≥ CTCAE v5.0 grade 2 infection);\n* Known human immunodeficiency virus (HIV) infection. A known history of liver disease with clinical significance, including viral hepatitis \\[People who are known to be carriers of hepatitis B virus (HBV) must exclude active HBV infection, that is, HBV DNA positive (\\>1 × 104 copies/mL or\\>2000 IU/ml); Known hepatitis C virus infection (HCV) and HCV RNA positive (\\>1 × 103 copies/mL);\n* Unrelieved toxic reaction caused by any previous anti-cancer treatment higher than CTCAE v5.0 grade 1 or above;\n* Routine urine test showed that urinary protein ≥ 2+, and 24-hour urinary protein volume\\>1.0g."}, 'identificationModule': {'nctId': 'NCT05575635', 'briefTitle': 'Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC', 'organization': {'class': 'OTHER', 'fullName': "Henan Provincial People's Hospital"}, 'officialTitle': 'A Single Arm, Single Center Clinical Study of Fruquintinib Combined With Concurrent Chemoradiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'HMPL-013-FLAG-C121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fruquintinib + mFOLFOX6 + radiotherapy', 'description': 'fruquintinib + mFOLFOX6 + radiotherapy', 'interventionNames': ['Drug: fruquintinib + concurrent radiotherapy + chemotherapy']}], 'interventions': [{'name': 'fruquintinib + concurrent radiotherapy + chemotherapy', 'type': 'DRUG', 'description': 'mFOLFOX6: The mFOLFOX6 regimen will be administered on Day 1 of each treatment cycle. This regimen consists of oxaliplatin 85 mg/m2 IV given over 2 hours, leucovorin 400 mg/m2 IV given over 2 hours, and fluorouracil 400 mg/m2 IV bolus, followed by fluorouracil 1200 mg/m2 per day for 2 days, continuous infusion.\n\nfruquintinib: 3mg/d, qd po, for 7 weeks continuously.\n\nRadiation Therapy: radiation 45.0\\~50.0 Gy (1.8-2.0 Gy/day or 25 fractions weeks 3-7)', 'armGroupLabels': ['fruquintinib + mFOLFOX6 + radiotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mingyue Liu, M.D.', 'role': 'CONTACT', 'email': 'liumingyuezz@163.com', 'phone': '18638927799'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liu Ming Yue', 'investigatorAffiliation': "Henan Provincial People's Hospital"}}}}