Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT06762158
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-31', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2024-12-31', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathologically complete response(pCR)', 'timeFrame': 'From date of surgery to 4 weeks later', 'description': 'absence of viable tumor cells in the resected cancer specimen（ypT0N0）'}], 'secondaryOutcomes': [{'measure': 'event free survival', 'timeFrame': '24 months', 'description': 'From date of treatment until the date of death from any cause or the date of disease progression, assessed up to 24 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal squamous cell cancer', 'neoadjuvant chemoradiotherapy', 'perioperative immunotherapy', 'PD-1 inhibitor'], 'conditions': ['Esophageal Squamous Cell Carcinoma (ESCC)']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the efficacy of the combination of neoadjuvant chemoradiotherapy and perioperative PD-1 inhibitor in patients with locally advanced esophageal squamous cell cancer and explore the predictive biomarkers for this regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years old\n* Histologically or cytologically confirmed esophageal squamous cell cancer\n* Stage T3-4aN0M0 or TanyN1-3M0 according to the American Joint Committee on Cancer staging manual eighth edition\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* he indexes of hematology, biochemistry and organ function meet the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L；b. neutrophil count (ANC) ≥ 1.5×109/L; c. platelets ≥ 85×109/L; d. hemoglobin ≥ 90g/L; e. total bilirubin ≤ 1.5 ULN; f. ALT ≤ 1.5 ULN; g. creatinine clearance rate \\>60 mL/min;\n* The cardiopulmonary function needs to meet the following criteria: EF ≥ 55%, VC \\> 60%, FEV1 \\> 1.2L, FEV1%\\> 40%, DLco \\> 40%\n* Women of childbearing age must undergo a pregnancy test within 7 days before enrollment for treatment, and only those with a negative result can be enrolled\n* Voluntarily participating in this study\n\nExclusion Criteria:\n\n* Patients with active infection within 2 weeks before the first use of the study drug\n* A history of interstitial lung disease or non-infectious pneumonia\n* A history of autoimmune diseases or abnormal immune system\n* Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction\n* Patients diagnosed with any other malignant tumor within 5 years before enrollment, except for malignant tumors with low risk of recurrence and risk of death, such as fully treated basal cell or squamous cell skin and carcinoma in situ of the cervix;\n* Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs nab-paclitaxel or cisplatin\n* A history of immunodeficiency，including a positive HIV test result or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation\n* Women during pregnancy or lactation\n* Other situations not suitable for enrollment'}, 'identificationModule': {'nctId': 'NCT06762158', 'briefTitle': 'NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Neoadjuvant Chemoradiotherapy Combined With Sequential Perioperative PD-1 Inhibitor for Locally Advanced Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'LY2024-217-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perioperative toripalimab', 'description': 'neoadjuvant chemoradiotherapy and perioperative toripalimab', 'interventionNames': ['Radiation: Neoadjuvant Chemoradiotherapy', 'Drug: neoadjuvant immunotherapy', 'Procedure: Surgery', 'Drug: adjuvant immunotherapy']}], 'interventions': [{'name': 'Neoadjuvant Chemoradiotherapy', 'type': 'RADIATION', 'description': 'Neoadjuvant chemoradiotherapy:\n\n1. Radiation dose: 1.8Gy/Fx, DT41.4Gy/23Fx.\n2. Concurrent chemotherapy: Albumin-bound paclitaxel 60mg/m² + Cisplatin 25mg/m² on D1, D8, D15, D22, D29.', 'armGroupLabels': ['Perioperative toripalimab']}, {'name': 'neoadjuvant immunotherapy', 'type': 'DRUG', 'description': 'Begins on the second day after the completion of concurrent chemoradiotherapy, and no later than one week. Toripalimab 240mg Q3W, for a total of two cycles.', 'armGroupLabels': ['Perioperative toripalimab']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Preoperative assessment is conducted 3 weeks after the last neoadjuvant immunotherapy, and surgery is performed within 4-6 weeks. All patients undergo minimally invasive radical esophagectomy, either McKeown or Ivor-Lewis, with extended two-field or three-field lymph node dissection.', 'armGroupLabels': ['Perioperative toripalimab']}, {'name': 'adjuvant immunotherapy', 'type': 'DRUG', 'description': 'Whether to undergo postoperative adjuvant immunotherapy is determined based on the pathological response. Patients with pCR are only observed without receiving adjuvant treatment, while those not reaching pCR receive one year of adjuvant Toripalimab.', 'armGroupLabels': ['Perioperative toripalimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}