Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05086627
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2021-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'C519688', 'term': 'XELOX'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological complete response rate', 'timeFrame': '1 week after surgery', 'description': 'Pathological complete response rate was defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)'}], 'secondaryOutcomes': [{'measure': 'major pathologic response (TRG0+TRG1)', 'timeFrame': '1 week after surgery', 'description': 'TRG 0 indicates no remaining viable cancer cells (complete response); TRG 1 indicates a single cell or small groups of cancer cells (moderate response)'}, {'measure': '3-year PFS', 'timeFrame': '3 years from randomization', 'description': 'PFS refers to the time from randomization to tumor progresses or death from any cause'}, {'measure': '3-year OS', 'timeFrame': '3 years from randomization', 'description': 'OS refers to the time from randomization to death from any cause'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Incidence of Treatment-Emergent Adverse Events \\[Safety and Tolerability\\] during treatment, including chemoradiotherapy, immunology, sugery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally advanced rectal cancer', 'Neoadjuvant radiotherapy', 'Immune checkpoint inhibitors', 'Programmed death-1 inhibitor'], 'conditions': ['Locally Advanced Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.', 'detailedDescription': "Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, CA-724 β2-microglobulin, Ferroprotein), chest CT, abdominal and pelvic MRI, etc., were required to undergo KRAS, NRAS, BREF, PD-L1, MMR/MSS testings before SCRT, and blood lymphocyte subgroups were analyzed before SCRT, systemic therapy, and surgery.\n\nSubjects in group A will be treated according to the following treatment plan:\n\nStandard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)\n\nSequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX.\n\nSurgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.\n\nPostoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases.\n\nSubjects in group B will be treated according to the following treatment plan:\n\nStandard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)\n\nSequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14).\n\nSurgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.\n\nPostoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases.\n\nEndpoint: The primary endpoint was pCR rate. Secondary endpoints included MPR (TRG0+TRG1), 3-year PFS, 3-year OS, and treatment safety.\n\nFollow-up records during treatment: For the duration of operation, the time required to complete the TME surgery and the amount of blood loss were recorded, and the impact of neoadjuvant therapy on the operation was observed. During the SCRT process, and the period of resting after SCRT, of the entire preoperative systemic treatment, of the resting after TME surgery, of the postoperative chemotherapy (these willing cases), the occurrence of adverse events (AE) of participants were closely monitored and actively responded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients or their family members agree to participate in the study and sign the informed consent form;\n\nPatients ≥ 18 and ≤75 years old, male or female;\n\nECOG performance status of 0 or 1;\n\nPatients with histologically confirmed rectal adenocarcinoma;\n\nThe clinical diagnosis of chest CT, abdominal and pelvic enhanced MRI was T1-2N+M0 and cT3-4NanyM0 (the T and N stage was based on pelvic enhanced MRI+DWI, M stage was determined by liver enhanced MRI+DWI and chest CT, and if necessary, PET-CT was used);\n\nThe distance between the lower edge of the tumor and the anal edge is less than or equal to 10 cm;\n\nNo history of immune system diseases;\n\nNo history of immunodeficiency, including HIV positive;\n\nNo history of other malignancies;\n\nNo history of myocarditis;\n\nNo history of severe cardiovascular and cerebrovascular diseases;\n\nNo history of thyroid dysfunction;\n\nNo history of liver and kidney diseases;\n\nNo history of mental illness, no history of Infectious diseases;\n\nNo history of organ transplantation or allogeneic bone marrow transplantation;\n\nThere is no history of other systemic diseases other than the above diseases;\n\nVoluntarily accept the neoadjuvant treatment scheme of radiotherapy, sequential chemotherapy / chemotherapy combined with immunotherapy;\n\nSwallowing pills normally;\n\nRectal cancer without radiotherapy, chemotherapy, surgery, Chinese medicine anti-tumor treatment, etc.;\n\nSurgical treatment is planned after neoadjuvant treatment.\n\nExclusion Criteria:\n\nPatients who do not meet the above inclusion criteria;\n\nDocumented history of allergy to study drugs, including any component of Tislelizumab, capecitabine, oxaliplatin and other platinum drugs;\n\nPatients who need to be treated with corticosteroid (dose equivalent to prednisone of \\>10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Major surgery or severe trauma within 4 weeks before the first use of the study drug;\n\nSevere infection (CTCAE \\> 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;\n\nFemale patients who is pregnant or breastfeeding;\n\nPatients who refuse to sign informed consent by themselves or their authorized persons;\n\nPatients with poor cognitive ability, unable to answer questions, unable to fill in questionnaires or mental disorders;\n\nPatients considered unsuitable for the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT05086627', 'briefTitle': 'Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Fourth Hospital'}, 'officialTitle': 'A Single -Centers, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': '2021104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)', 'description': "Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)\n\nSequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX.\n\nSurgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.\n\nPostoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases.", 'interventionNames': ['Drug: Tislelizumab', 'Radiation: Short-course radiotherapy', 'Drug: Capecitabine+Oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Short-course radiotherapy sequential CapeOX (group B)', 'description': "Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)\n\nSequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14).\n\nSurgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.\n\nPostoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases.", 'interventionNames': ['Radiation: Short-course radiotherapy', 'Drug: Capecitabine+Oxaliplatin']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'description': 'Patients were treated with Tislelizumab on the first day of each cycle of CapeOX (Capecitabine+Oxaliplatin).', 'armGroupLabels': ['Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)']}, {'name': 'Short-course radiotherapy', 'type': 'RADIATION', 'description': 'Patients were treated with short-course neoadjuvant radiotherapy', 'armGroupLabels': ['Short-course radiotherapy sequential CapeOX (group B)', 'Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)']}, {'name': 'Capecitabine+Oxaliplatin', 'type': 'DRUG', 'description': 'Patients were treated with neoadjuvant chemotherapy with CapeOX (Capecitabine+Oxaliplatin).', 'armGroupLabels': ['Short-course radiotherapy sequential CapeOX (group B)', 'Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050011', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}