Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT06281405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711728', 'term': 'spartalizumab'}, {'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D000069287', 'term': 'Capecitabine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-25', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-25', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response (CR) rate', 'timeFrame': '1 month after the surgery or the decision of W&W', 'description': 'Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\\&W strategy.'}], 'secondaryOutcomes': [{'measure': 'Grade 3-4 adverse effects rate', 'timeFrame': 'From date of randomization until 3 months after the completion neoadjuvant therapy', 'description': 'Rate of chemotherapy, radiotherapy and immunotherapy related adverse events'}, {'measure': '3 year anal preservation rate', 'timeFrame': 'From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 36 months.', 'description': '3 year anal preservation rate'}, {'measure': '3 year disease free survival rate', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.', 'description': 'Rate of 3 year disease free survival'}, {'measure': '3 year local recurrence free survival rate', 'timeFrame': 'From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.', 'description': 'Rate of 3 year local recurrence free survival'}, {'measure': '3 year overall survival rate', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 36 months.', 'description': 'Rate of 3 year overall survival'}, {'measure': 'Rate of surgical complications', 'timeFrame': 'The surgical complications were assessed within 3 months after the surgery.', 'description': 'Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Rectal Cancer', 'Neoadjuvant Therapy']}, 'descriptionModule': {'briefSummary': 'TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathological confirmed adenocarcinoma;\n2. Clinical stage T3-4 and/or N+;\n3. The distance from anal verge ≤ 12 cm;\n4. Without distance metastases;\n5. Age 18-70 years old, female and male;\n6. KPS ≥ 70;\n7. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\\^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;\n8. With good compliance and signed the consent form.\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding women;\n2. Known history of other malignancies within 5 years;\n3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;\n4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);\n5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;\n6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;\n7. Uncontrolled infection which needs systemic therapy;\n8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;\n9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection\n10. Allergic to any component of the therapy.'}, 'identificationModule': {'nctId': 'NCT06281405', 'acronym': 'TORCH-iTNT', 'briefTitle': 'CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)', 'orgStudyIdInfo': {'id': 'FDRT-2023-290-3409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunochemotherapy group', 'description': 'The patients will receive 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\\&W option can be applied to patients achieving cCR.', 'interventionNames': ['Drug: PD-1 antibody', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Radiation plus immunochemotherapy group', 'description': 'The patients will receive short-course radiotherapy (25Gy/5Fx), followed by 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\\&W option can be applied to patients achieving cCR.', 'interventionNames': ['Drug: PD-1 antibody', 'Drug: Capecitabine', 'Radiation: Short-course radiotherapy']}], 'interventions': [{'name': 'PD-1 antibody', 'type': 'DRUG', 'otherNames': ['Toripalimab'], 'description': 'PD-1 antibody (Toripalimab): 240mg d1 q3w', 'armGroupLabels': ['Immunochemotherapy group', 'Radiation plus immunochemotherapy group']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine: 1000mg/m2 bid d1-14 q3w', 'armGroupLabels': ['Immunochemotherapy group', 'Radiation plus immunochemotherapy group']}, {'name': 'Short-course radiotherapy', 'type': 'RADIATION', 'description': 'Short-course radiotherapy: 25Gy/5Fx', 'armGroupLabels': ['Radiation plus immunochemotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhen Zhang, MD', 'role': 'CONTACT', 'email': 'zhen_zhang@fudan.edu.cn', 'phone': '18801735029'}, {'name': 'Yaqi Wang, MD', 'role': 'CONTACT', 'email': '10301010093@fudan.edu.cn', 'phone': '18121299593'}], 'overallOfficials': [{'name': 'Zhen Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Zhen Zhang', 'investigatorAffiliation': 'Fudan University'}}}}