Spots Global Cancer Trial Database for Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma
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Trial Identification
Brief Title: Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma
Official Title: Efficacy and Safety of Concurrent Sintilimab and Radiotherapy With Immunonutrition Support in Esophageal Cancer: A Phase II Multicenter Clinical Trial
Study ID: NCT06342167
Study Description
Brief Summary: 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.
Detailed Description: This single-arm trial is designed to evaluate the efficacy and safety of concurrent immunotherapy (sintilimab) plus radiotherapy with immunonutrition support (enteral nutritional emulsion (TPF-T) followed by consolidation immunotherapy in patients with LA-ESCC and PD-L1 positive expression who are intolerant to cCRT. The eligible patients will receive concurrent treatment consisting of total dose of 50-50.4 Gy in 25-28 fractions and 200 mg of sintilimab administered every three weeks, along with enteral nutritional emulsion (TPF-T) support (600-1600 ml per day according to the nutrition status evaluation). The primary outcome is 1-year progression-free survival (PFS) rate. The investigators hypothesized PD-L1 inhibitor plus radiotherapy will improve the 1-year PFS from 40% to 60%. Then, 58 patients will be needed in total. The secondary outcomes will include objective response rate (ORR), overall survival (OS), progression-free and overall survival, and incidence of adverse events. This study is approval by the National GCP Center for Anticancer Drugs, Independent Ethics Committee, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College (Study ID: 24/074-4354).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, Beijing, China
Department of Radiation Oncology，Clinical Oncology School of Fujian Medical University，Fujian Cancer Hospital, Fujian, Fujian, China
Department of Oncology, Affiliated Hospital, Hebei University of Engineering, Handan, Hebei, China
Department 1st of Radiation Oncology, Anyang Tumor Hospital, Anyang, Henan, China
Department of Radiation Oncology the first affiliated hospital of Xinxiang Medical University, Xinxiang, Henan, China
Department of Radiation Oncology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China
Department of Radiation Oncology，Fei County People's Hospital, Feixian, Shandong, China
Department of Radiation Oncology, Affiliated hospital of Jining Medical University, Jining, Shandong, China
Taizhou hospital of Wenzhou Medical University, Taizhou, Zhejiang, China
Contact Details
Name: Jianyang Wang, MD
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Role: STUDY_DIRECTOR
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