protocolSection identificationModule nctId: NCT06342167, orgStudyIdInfo id: NCC4409, briefTitle: Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT., conditionsModule conditions: Locally Advanced Esophageal Squamous Cell Carcinoma, conditions: Sintilimab, conditions: Radiotherapy, conditions: Concurrent Chemoradiotherapy, conditions: Immunonutrition, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 57, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, interventions name: Programmed Cell Death Protein 1 Inhibitor, interventions name: Immunonutrition support, outcomesModule primaryOutcomes measure: 1-year Progression-free survival rate (PFS), secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, city: Beijing, state: Beijing, zip: 100021, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Department of Radiation Oncology，Clinical Oncology School of Fujian Medical University，Fujian Cancer Hospital, city: Fujian, state: Fujian, country: China, locations facility: Department of Oncology, Affiliated Hospital, Hebei University of Engineering, city: Handan, state: Hebei, country: China, geoPoint lat: 36.60056, lon: 114.46778, locations facility: Department 1st of Radiation Oncology, Anyang Tumor Hospital, city: Anyang, state: Henan, country: China, geoPoint lat: 36.096, lon: 114.38278, locations facility: Department of Radiation Oncology the first affiliated hospital of Xinxiang Medical University, city: Xinxiang, state: Henan, country: China, geoPoint lat: 35.19033, lon: 113.80151, locations facility: Department of Radiation Oncology, General Hospital of Ningxia Medical University, city: Yinchuan, state: Ningxia, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Department of Radiation Oncology，Fei County People's Hospital, city: Feixian, state: Shandong, country: China, locations facility: Department of Radiation Oncology, Affiliated hospital of Jining Medical University, city: Jining, state: Shandong, country: China, geoPoint lat: 35.405, lon: 116.58139, locations facility: Taizhou hospital of Wenzhou Medical University, city: Taizhou, state: Zhejiang, zip: 317000, country: China, geoPoint lat: 32.49069, lon: 119.90812, hasResults: False