Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-31 @ 5:47 AM
Study NCT ID:
NCT07239466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer
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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response (CR) rate', 'timeFrame': 'an expected average of 12 months', 'description': 'Defined as pathological complete response (pCR) + Clinical complete response (cCR)'}], 'secondaryOutcomes': [{'measure': '3-year disease-Free Survival', 'timeFrame': 'an expected average of 3 years', 'description': 'The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first'}, {'measure': 'Overall Survival', 'timeFrame': 'an expected average of 5 years', 'description': 'The time from the date of randomization to the death caused by any cause'}, {'measure': 'Adverse events (AEs) were graded according to the NCI CTCAE version 5·0', 'timeFrame': 'an expected average of 1.5 years', 'description': 'Adverse events and surgical safety'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer', 'Radiotherapy', 'Immunotherapy', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'This study is a prospective phase II clinical trial aimed at exploring the potential benefits of supplementing β-hydroxybutyrate with existing short course radiotherapy sequential immunotherapy and CAPEOX therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients or their family members agree to participate in the study and sign the informed consent form;\n2. Age 18-75 years, male or female;\n3. Histologically confirmed Locally Advanced rectal adenocarcinoma;\n4. inferior margin ≤ 10 cm from the anal verge;\n5. ECOG performance status score is 0-1;\n6. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;\n7. There was no operative contraindication;\n8. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n9. Urinary protein \\< 2+ or 24-hour urinary protein excretion \\< 1 g at baseline.\n\nExclusion Criteria:\n\n1. Patients with non-pMMR LARC；\n2. Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;\n3. Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).'}, 'identificationModule': {'nctId': 'NCT07239466', 'briefTitle': 'A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'A Single-Arm, Single-Center Study of Exploring the β-hydroxybutyrate Supplementation and Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'Union-BHB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Radiotherapy (SCRT): Total dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days).\n\nβ-hydroxybutyrate: Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks).\n\nImmunotherapy (PD-1 monoclonal antibody): 200 mg via intravenous infusion every 3 weeks (q3w) for 2 cycles, initiated 1 week after radiotherapy completion.\n\nChemotherapy (CAPEOX regimen): Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; total of 2 cycles during the neoadjuvant phase.', 'interventionNames': ['Radiation: Short-course radiotherapy', 'Drug: Capecitabine', 'Drug: Oxaliplatin', 'Procedure: TME surgery', 'Dietary Supplement: β-hydroxybutyrate']}], 'interventions': [{'name': 'Short-course radiotherapy', 'type': 'RADIATION', 'description': 'Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.', 'armGroupLabels': ['experimental group']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': '1000mg/m2, bid, po, d1-14,q3w', 'armGroupLabels': ['experimental group']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': '130mg/m2, ivgtt, d1,q3w', 'armGroupLabels': ['experimental group']}, {'name': 'TME surgery', 'type': 'PROCEDURE', 'description': 'The surgery was performed 1 week after the end of neoadjuvant therapy.', 'armGroupLabels': ['experimental group']}, {'name': 'β-hydroxybutyrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks).', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Tao Zhang, MD', 'role': 'CONTACT', 'email': '1277577866@qq.com', 'phone': '027-83262683'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Zhenyu Lin, MD', 'role': 'CONTACT', 'email': 'whxhlzy@hust.edu.cn', 'phone': '027-83262683'}, {'name': 'Tao Zhang, MD', 'role': 'CONTACT', 'email': 'whxhlzy@hust.edu.cn'}], 'overallOfficials': [{'name': 'Zhenyu Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huazhong University of Science and Technology Tongji Medical College Union Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tao Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tao Zhang', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}