Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT05111860
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri-operative complications', 'timeFrame': 'From the start of treatment to 3 months after surgery', 'description': 'Complications occurring in the perioperative period'}], 'secondaryOutcomes': [{'measure': 'Pathological response rate', 'timeFrame': '2 weeks after surgery', 'description': 'Tumor Regression Grade 0-1'}, {'measure': 'Pathological complete response rate', 'timeFrame': '2 weeks after surgery', 'description': 'Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0)'}, {'measure': '2-year local control rate', 'timeFrame': '2 years', 'description': 'Refers to the probability of not finding local recurrence of tumor within 2 years，including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit.'}, {'measure': '2-year metastasis-free rate', 'timeFrame': '2 years', 'description': 'Refers to the probability of no distant metastasis within 2 years'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Refers to the time from the start of treatment to death due to any cause.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoadjuvant Treatment', 'Rectal Cancer', 'Bevacizumab', 'Radiotherapy']}, 'descriptionModule': {'briefSummary': 'Prospectively Investigate the effectiveness and safety of neoadjuvant Bevacizumab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS mutant-type locally advanced rectal cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A biopsy proven histological diagnosis of rectal adenocarcinoma；\n2. An ARMS-PCR proven KRAS, NRAS mutation, excluding BRAF mutation or microsatellite instablility-High;\n3. No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;\n4. MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;\n5. Age between 18-75 years;\n6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1;\n7. Has sufficient organ function:\n\n * Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L,\n * neutrophils ≥ 1.5 × 109/L\n * Liver function: ALT and AST \\< 2.5 × ULN;\n * Renal function: serum creatinine \\< 1.5 ULN;\n8. Willing to participate and informed consent signed；\n\nExclusion Criteria:\n\n1. An ARMS-PCR proven RAS wild type, BRAF mutation and microsatellite instablility-High;\n2. Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;\n3. Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;\n4. Female patients who are pregnant or breastfeeding;\n5. Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;\n6. Patients with active infection;\n7. Poor overall health status, ECOG ≥ 2;\n8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;\n9. Known hypersensitivity reactions to any investigational drugs;'}, 'identificationModule': {'nctId': 'NCT05111860', 'briefTitle': 'Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Minimally Invasive Surgery Center'}, 'officialTitle': 'Efficacy and Safety of Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy for RAS Mutant-type Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'MISC-Bev-SCRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Drug: Bevacizumab+mFOLFOX6']}], 'interventions': [{'name': 'Bevacizumab+mFOLFOX6', 'type': 'DRUG', 'description': 'Bevacizumab 5mg/kg d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200020', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenghao Cai', 'role': 'CONTACT', 'email': 'c3z2h1@alumni.sjtu.edu.cn', 'phone': '+862164458887'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhenghao Cai, MD', 'role': 'CONTACT', 'email': 'c3z2h1@alumni.sjtu.edu.cn', 'phone': '+862164458887'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Minimally Invasive Surgery Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}