Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-29 @ 4:21 AM
Study NCT ID:
NCT06889402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-21
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Analysis of Esophageal Cancer with Complete Pathological Response After Neoadjuvant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D000095384', 'term': 'Pathologic Complete Response'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Metastasis rate of different parts or organs', 'timeFrame': 'The postoperative follow-up period should last for at least one year.'}], 'primaryOutcomes': [{'measure': 'Disease-Free Survival', 'timeFrame': 'The postoperative follow-up period should last for at least one year.', 'description': 'The time from the postoperative period of the patient to the first occurrence of recurrence or metastasis.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival Rate', 'timeFrame': 'The postoperative follow-up period should last for at least one year.', 'description': 'the proportion of patients who are still alive for a certain period of time after surgery among all the patients who have undergone the surgical operation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Complete pathological response', 'neoadjuvant', 'Recurrence', 'Esophageal Squamous Cell Carcinoma', 'Survival'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. Currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. Neoadjuvant treatment regimens include chemotherapy, chemoradiotherapy, and chemotherapy combined with immunotherapy. Complete pathological response (pCR)is currently regarded as one of the important indicators for evaluating the efficacy of neoadjuvant treatment. Previous studies have shown that 14%-39% of patients with complete pathological response after neoadjuvant treatment still experience recurrence and metastasis within two years after surgery, suggesting that pCR after esophageal cancer surgery does not mean clinical cure. Perhaps there is a highly risk clinical subgroup need to research. Therefore, based on the prospective clinical database of the National Cancer Center and in cooperation with multiple national cancer regional medical centers, this study analyzes and explores the prognosis of patients with locally advanced esophageal squamous cell carcinoma with pCR after neoadjuvant treatment, characterized by the Chinese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with thoracic esophageal squamous cell carcinoma treated neoadjvant treatment followed by esophagectomy from 2018 to 2023,whose preoperative clnical stage was cT1N+M0/cT2-4aN0-3M0, with potential resectability and the ypstage ypT0N0M0（complete pathological response ）', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated neoadjvant treatment followed by esophagectomy from 2018 to 2023\n* Patients with thoracic esophageal squamous cell carcinoma\n* The preoperative clnical stage is cT1N+M0/cT2-4aN0-3M0, with potential resectability\n* Patients with complete pathological response (ypT0N0M0)\n* Without distant metastasis was found in the preoperative examinations, and the tumor did not directly invade the pancreas, spleen, trachea, aorta or other adjacent organs such as the lungs\n\nExclusion Criteria:\n\n* Patients with previous history of malignant tumors\n* Patients with multiple primary cancers\n* Deficient neoadjuvant treatment or salvage surgery\n* Incomplete clinical data'}, 'identificationModule': {'nctId': 'NCT06889402', 'briefTitle': 'Prognostic Analysis of Esophageal Cancer with Complete Pathological Response After Neoadjuvant Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Risk Factors for Recurrence and Survival Outcomes of Esophageal Squamous Cell Carcinoma Patients with Complete Pathological Response After Neoadjuvant Therapy：A Multicenter Study', 'orgStudyIdInfo': {'id': 'AESCNT01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recurrence', 'description': 'Patients with complete pathological response after neoadjuvant treatment experience recurrence or metastasis after surgery', 'interventionNames': ['Procedure: Neoadjuvant therapy with PD-L1 inhibitor']}, {'label': 'Non-recurrence', 'description': 'Patients with complete pathological response after neoadjuvant treatment without recurrence or metastasis after surgery', 'interventionNames': ['Procedure: Neoadjuvant therapy with PD-L1 inhibitor']}], 'interventions': [{'name': 'Neoadjuvant therapy with PD-L1 inhibitor', 'type': 'PROCEDURE', 'otherNames': ['neoadjuvant chemotherapy', 'neoadjuvant chemoradiotherapy'], 'description': 'During neoadjuvant treatment, patients may receive neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy, or neoadjuvant chemotherapy combined with immunotherapy during the perioperative period.', 'armGroupLabels': ['Non-recurrence', 'Recurrence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Xiufeng Wei', 'role': 'CONTACT', 'email': '383775613@qq.com', 'phone': '15836176692'}, {'name': 'Xiankai Chen', 'role': 'CONTACT', 'email': 'xiufeng-wei1990@hotmail.com', 'phone': '18239900587'}], 'facility': 'Section of Esophageal and Mediastinal Oncology, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}