Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT07236320
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Immunochemotherapy vs Chemoradiotherapy in ESCC
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'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '5 years', 'description': 'Time from first treatment to death from any cause or last follow-up.'}, {'measure': 'Disease-Free Survival (DFS)', 'timeFrame': '5 years', 'description': 'Time from surgery to recurrence, death, or last follow-up.'}], 'secondaryOutcomes': [{'measure': 'Pathological Complete Response (pCR) rate', 'timeFrame': '3 months'}, {'measure': 'Tumor Regression Grade (TRG)', 'timeFrame': '3 months'}, {'measure': 'R0 resection rate', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma (ESCC)']}, 'descriptionModule': {'briefSummary': 'This retrospective real-world study aimed to compare neoadjuvant immunochemotherapy (NICT) and neoadjuvant chemoradiotherapy (NCRT) followed by esophagectomy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). A total of 203 consecutive patients treated at Sichuan Cancer Hospital between March 2018 and March 2022 were analyzed (NICT: 59; NCRT: 144). The primary endpoints were overall survival (OS) and disease-free survival (DFS); secondary endpoints included pathological complete response (pCR), tumor regression grade (TRG), and R0 resection rate. After inverse probability of treatment weighting adjustment, baseline characteristics were balanced between groups. Both groups achieved comparable long-term OS and DFS, while NCRT showed higher rates of local pathological response. Exploratory subgroup analysis suggested that patients achieving pCR after NICT might have superior survival outcomes. The study indicates that NICT provides similar long-term survival compared to NCRT and may offer immunologic advantages for selected responders, warranting further validation in prospective multicenter trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Histologically confirmed thoracic ESCC\n* Clinical stage cT1N+M0 or cT2-4aN0-3M0\n* Received neoadjuvant therapy (immunochemotherapy or chemoradiotherapy) followed by esophagectomy\n\nExclusion Criteria:\n\n* History of other malignancies\n* Did not complete neoadjuvant therapy or required salvage surgery\n* Incomplete baseline or follow-up data'}, 'identificationModule': {'nctId': 'NCT07236320', 'briefTitle': 'Neoadjuvant Immunochemotherapy vs Chemoradiotherapy in ESCC', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan Cancer Hospital and Research Institute'}, 'officialTitle': 'Neoadjuvant Immunochemotherapy Versus Chemoradiotherapy in Locally Advanced Esophageal Cancer: A Real-World Study', 'orgStudyIdInfo': {'id': 'SCCH-TS2503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NICT group', 'interventionNames': ['Drug: Neoadjuvant immunochemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NCRT group', 'interventionNames': ['Drug: Neoadjuvant Chemoradiotherapy']}], 'interventions': [{'name': 'Neoadjuvant immunochemotherapy', 'type': 'DRUG', 'description': 'NACI group patients received treatment of minimally 2 cycles of ICIs agent (mainly camrelizumab or toripalimab, 200 mg every 3 weeks (200 mg every 3 weeks)) combined with concurrent chemotherapy.', 'armGroupLabels': ['NICT group']}, {'name': 'Neoadjuvant Chemoradiotherapy', 'type': 'DRUG', 'description': 'NCRT group patients followed the concurrent NCRT treatment, and the total neoadjuvant radiotherapy dose was 40.0-50.4Gy with 1.8-2.14 Gy fractions and 5 fractions/week.', 'armGroupLabels': ['NCRT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichuan Cancer Hospital and Institute', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data (IPD) will not be shared because this is a retrospective study based on patient medical records, and the data contain potentially identifiable clinical information. Ethical approval for this study was granted under the condition that data would be used only for internal analysis at Sichuan Cancer Hospital \\& Institute. De-identified summary-level results are provided within the publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yongtao Han', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Surgeon / Professor, Department of Thoracic Surgery', 'investigatorFullName': 'Yongtao Han', 'investigatorAffiliation': 'Sichuan Cancer Hospital and Research Institute'}}}}