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.
Aged 18 years or order.
Diagnosed with locally advanced or early stage esophageal squamous cell carcinoma by pathological examinations of the primary lesion and imaging examinations, which are not resectable.
Confirmed to be unresectable and unable to tolerate synchronous chemoradiotherapy by multidisciplinary consultation, and has not undergone systemic drug therapy in the past.
PD-L1 tumor proportion score or combined positive score of ≥1%.
A high risk of bleeding or perforation due to clear invasion of adjacent organs (large arteries or trachea) by the tumor, or with fistula.
Diagnosed with malignancies other than esophageal cancer within 3 years prior to the first dose (excluding cured basal cell carcinoma or squamous cell carcinoma of the skin and/or radically resected carcinoma in situ).
Previous immunological or immunomodulatory drugs as systemic whole-body treatment, including thymic peptides, interferon, interleukins, except for local use to control pleural effusion.
Previous chest radiotherapy.
Single group
Radiotherapy
RadiationInterventions consist of 50-60 Gy in 25-30 fractions of radiotherapy.
Programmed Cell Death Protein 1 Inhibitor
Drug200 mg of Sintilimab administered every three weeks concurrently with radiotherapy and after radiotherapy as consolidation therapy up to 1year.
Immunonutrition support
Dietary supplement600-1600 ml of TPF-T per day according to the nutrition status evaluation
1-year Progression-free survival rate (PFS)
Progression-free survival rate is defined the rate of progress event at 1-years after radiotherapy. Progression event is defined as event of primary tumor and regional recurrence, or distant metastasis
Objective response rate
Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Progression-free survival
Progression-free survival is defined as the time from treatment to the event of primary tumor and regional recurrence, or distant metastasis
Overall survival rate
Live rate at months 6, 12, 18, and 24.
Overall survival
Live status at different time points.
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