Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05659251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2022-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma
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': 'D016629', 'term': 'Esophagectomy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2022-12-13', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (PCR)', 'timeFrame': '1 month after surgery', 'description': 'No residual invasive tumor cells were found in the pathological examination of resected specimens, including the primary tumor and lymph nodes.'}], 'secondaryOutcomes': [{'measure': 'major pathological response (MPR)', 'timeFrame': '1 month after surgery', 'description': 'In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'before surgery', 'description': 'The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria'}, {'measure': '2-year and 5-year overall survival', 'timeFrame': '2-year and 5-year after surgery', 'description': 'The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after surgery'}, {'measure': 'Incidence of Treatment-related Adverse Events', 'timeFrame': '1 month after surgery', 'description': 'Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0'}, {'measure': 'R0 resection rate', 'timeFrame': '1 month after surgery', 'description': 'The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope'}, {'measure': 'The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients', 'timeFrame': '3 months after surgery', 'description': 'By using mass spectrometry (CyTOF) and single-cell analysis, we comprehensively characterized the immune landscape in the peripheral blood and tumor sample of ESCC patients before and after anti-PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['serplulimab', 'Esophageal Squamous Cell Carcinoma', 'Neoadjuvant Treatment'], 'conditions': ['Esophageal Squamous Cell Carcinoma', 'Neoadjuvant Therapy']}, 'referencesModule': {'references': [{'pmid': '41423619', 'type': 'DERIVED', 'citation': 'Wu Z, Wu C, Wang Y, Liang F, Qi L, Wang K, Shen G, Li J, Shen H, Wu M. Neoadjuvant serplulimab combined with chemotherapy for resectable oesophageal squamous cell carcinoma: a single-arm, phase 2 trial. Nat Commun. 2025 Dec 21. doi: 10.1038/s41467-025-67589-5. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced esophageal cancer. However, in patients with locally advanced esophageal cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of silulimab combined with chemotherapy in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. signed informed consent;\n2. patients age 18 to 75 years old\n3. primary resectable, histologically confirmed esophageal squamous cell cancer;\n4. Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).\n5. ECOG PS 0-1.\n6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;\n\nExclusion Criteria:\n\n1. with significant cardiovascular disease;\n2. current treatment with anti-viral therapy or HBV;\n3. Female patients who are pregnant or lactating;\n4. history of malignancy within 5 years prior to screening;\n5. active or history of autoimmune disease or immune deficiency;\n6. signs of distant metastases.'}, 'identificationModule': {'nctId': 'NCT05659251', 'briefTitle': 'Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '2022-1022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serplulimab', 'description': 'Preoperative neoadjuvant therapy for 3 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient.\n\nSerplulimab can be maintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.', 'interventionNames': ['Combination Product: Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy', 'Procedure: Esophagectomy', 'Other: sample']}], 'interventions': [{'name': 'Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Serplulimab 4.5mg/kg, IV, Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days.', 'armGroupLabels': ['Serplulimab']}, {'name': 'Esophagectomy', 'type': 'PROCEDURE', 'description': 'Prior to each surgical procedure, the department engaged in comprehensive discussions and deliberations to ascertain and establish the most suitable course of action. Minimally invasive Ivor-Lewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two field extensive lymphadenectomies, was performed according to the tumor location. The resection length should be at least 5cm from the tumor origin according to prechemotherapy by endoscopy.\n\nThe surgeries will be performed by surgeons with rich experience. Minimally invasive esophagectomy, can be performed using the da Vinci surgical robot, thoracoscope, or laparoscope, or by using an open approach, as judged appropriate by the surgeon.', 'armGroupLabels': ['Serplulimab']}, {'name': 'sample', 'type': 'OTHER', 'description': 'Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use.\n\n5 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery.\n\nTumour sample will be collected before neoadjuvant therapy and after surgery.', 'armGroupLabels': ['Serplulimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'China', 'country': 'China', 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Weilin Wang', 'role': 'STUDY_CHAIR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}