Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-06 @ 6:39 AM
Study NCT ID:
NCT06861894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable 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': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year OS rate', 'timeFrame': '24 months', 'description': 'An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.'}], 'secondaryOutcomes': [{'measure': 'cCR rate', 'timeFrame': '12 months', 'description': 'A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions.'}, {'measure': 'median EFS', 'timeFrame': '24 months', 'description': 'An event-free survival (EFS) is defined as the duration from the start of treatment until disease recurrence or death from any cause, whichever occurs first.'}, {'measure': 'median OS', 'timeFrame': '24 months', 'description': 'An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.'}, {'measure': 'Incidence, type and severity of adverse events as assessed by CTCAE 5.0', 'timeFrame': '24 months', 'description': 'Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 adverse events and higher-grade will be reported.'}, {'measure': 'quality of life (QOL)', 'timeFrame': '24 months', 'description': 'Evaluate quality of life using EORTC QLQ-C30'}, {'measure': 'quality of life (QOL) assessed by EORTC QLQ-OES18', 'timeFrame': '24 months', 'description': 'Evaluate quality of life using EORTC QLQ-OES18'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with chemoradiotherapy. The primary endpoint is 2-year overall survival rate in this watch-and-wait cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects signed the informed consent and volunteered to participate in the study.\n2. Esophageal squamous cell carcinoma confirmed by histology or cytology.\n3. Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).\n4. Expect to have R0 resection\n5. In age from 18 to 75.\n6. ECOG PS: 0\\~1.\n7. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.\n8. No contraindications to surgery.\n9. Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5; APTT≤1.5×ULN\n10. Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to three months after last administration.\n11. Good compliance, willing to comply with follow-up schedules.\n\nExclusion Criteria:\n\n1. Subjects have received or are receiving any of:\n\n 1. anti-tumor interventions such as radiotherapy, chemotherapy, or other medications.\n 2. immunosuppressants or systemic glucosteroids (prednisone equivalence\\> 10mg/d) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence\\>10mg/d) is allowed if no known active autoimmune disease.\n 3. live vaccine within 4 weeks before the first administration.\n 4. major surgery or major injury within 4 weeks before the first administration.\n2. Cancer-related exclusion criteria\n\n 1. other cancers instead of ESCC\n 2. unresectable or metastatic ESCC\n 3. not comply with cⅡ-Ⅲ（cT2N1-2M0 or cT3N0-2M0, AJCC 8th）\n 4. Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, localized prostate cancer received radical surgery and ductal carcinoma in situ that have received radical treatment and do not need other treatment can be included)\n3. Other criteria\n\n 1. Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrhythmia that needs treatment\n 2. Subjects with any known active autoimmune disease\n 3. Pregnant or breastfeeding female\n 4. Presence of allergy or hypersensitivity to investigational medications\n 5. HIV-positive or active hepatitis B (HBsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis\n 6. Investigators assessed there might be other factors that cause subjects to withdraw.'}, 'identificationModule': {'nctId': 'NCT06861894', 'briefTitle': 'Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'MA-EC-II-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'perioperative treatment with adebrelimab and CRT', 'interventionNames': ['Drug: Adebrelimab and nab-paclitaxel and carboplatin', 'Radiation: Radiation', 'Procedure: standard oesophagectomy', 'Other: active surveillance']}], 'interventions': [{'name': 'Adebrelimab and nab-paclitaxel and carboplatin', 'type': 'DRUG', 'description': 'Adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy', 'armGroupLabels': ['perioperative treatment with adebrelimab and CRT']}, {'name': 'Radiation', 'type': 'RADIATION', 'description': 'concurrent chemoradiotherapy', 'armGroupLabels': ['perioperative treatment with adebrelimab and CRT']}, {'name': 'standard oesophagectomy', 'type': 'PROCEDURE', 'description': 'standard oesophagectomy', 'armGroupLabels': ['perioperative treatment with adebrelimab and CRT']}, {'name': 'active surveillance', 'type': 'OTHER', 'description': 'active surveillance', 'armGroupLabels': ['perioperative treatment with adebrelimab and CRT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Zhigang Li, MD, PhD', 'role': 'CONTACT', 'email': 'zhigang.li@shsmu.edu.com', 'phone': '18960619260'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhigang Li, MD, PhD', 'role': 'CONTACT', 'email': 'zhigang.li@shsmu.edu.com', 'phone': '86-18960619260'}, {'name': 'Zhichao Liu, MD, PhD', 'role': 'CONTACT', 'email': 'zhichao.liu@sjtu.edu.cn', 'phone': '86-15622175948'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhigang Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of Department of Esophageal Surgery', 'investigatorFullName': 'Zhigang Li', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}