Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-29 @ 10:41 AM
Study NCT ID:
NCT06250894
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response', 'timeFrame': '10 days after operation', 'description': 'No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '6 months after the recruitment of the last subject.', 'description': 'The Objective response rate (ORR) is defined as the proportion of patients with a complete response (CR) or a partial response (PR) to preoperative therapy. The ORR will be evaluated using the RESIST1.1 protocol.'}, {'measure': 'Disease-Free-Survival (DFS)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The time between the beginning of treatment and the observation of disease progression or death from any cause.'}, {'measure': 'Number of participants with AEs (Adverse Events)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on. The AEs will be evaluated using the CTCAE 5.0 protocol.'}, {'measure': 'Major pathologic response (MPR)', 'timeFrame': '10 days after operation', 'description': 'defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PD-1', 'Neoadjuvant Chemoradiotherapy', 'Gastroesophageal Junction Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70, male and female.\n* Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aNxM0 (AJCC v8), Siewert typed as type II-III.\n* No previous anti-tumor treatment.\n* ECOG score was 0-1.\n* Expected survival of ≥ 6 months\n* Adequate organ reserve function.\n\nExclusion Criteria:\n\n* Malignant disease other than gastric cancer (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ) diagnosed within 5 years.\n* Known Her-2 positive( IHC 3+ or FISH positve).\n* Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody\n* Severe allergic reaction to monoclonal antibody.\n* Receiving systemic glucocorticoid therapy within 7 days prior to the first dose of the study\n* Known endoscopic signs of active bleeding from the lesion'}, 'identificationModule': {'nctId': 'NCT06250894', 'briefTitle': 'Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'A Clinical Study of the Efficacy and Safety of Sintilimab in Combination With Chemotherapy (S-1/Oxaliplatin, SOX) and Radiotherapy for the Neoadjuvant Treatment of Locally Advanced Esophagogastric Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': '2018S00686'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant immunotherapy-chemoradiotherapy', 'description': 'This is a one arm study, enrolled locally advanced EGJ patients will receive Sintilimab (PD-1 inhibitor) and combined with preoperative chemoradiotherapy and operation.\n\ngeneric name：PD-1; dosage form：Injection; dosage：200mg (20ml)； frequency：every 3 weeks； duration：3 times before operation and 3-5 times after operation', 'interventionNames': ['Drug: PD-1inhibitor']}], 'interventions': [{'name': 'PD-1inhibitor', 'type': 'DRUG', 'description': 'Patients receive 3 cycles of preoperative chemotherapy with Sintilimab（PD-1 inbibitor） and SOX (every 3 weeks), followed by radiotherapy (total dose of 36-40Gy in 18-22 fractions) during cycle 1 of the combination. Radical surgery for gastric cancer will be performed within 4-6 weeks after completion of neoadjuvant treatment, followed by 3-5 cycles of postoperative adjuvant chemotherapy with the SOX regimen.', 'armGroupLabels': ['Neoadjuvant immunotherapy-chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Jin', 'role': 'CONTACT', 'email': 'minjin86@126.com', 'phone': '18807108606'}], 'facility': 'Min Jin', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}