Safety and efficacy of programmed cell death‐1 antibody SHR‐1210 combined with concurrent chemoradiotherapy to treat locally advanced esophageal squamous cell carcinoma: a study protocol for an exploratory single‐arm phase Ib trial

Abstract

Objective Esophageal squamous cell carcinoma (ESCC) is the most common pathological pattern in China, with poor prognosis due to its early and frequent metastasis. Definitive concurrent chemoradiotherapy is the standard treatment for inoperable locally advanced ESCC. Studies have shown promising efficacy of immune‐checkpoint inhibitors in ESCC. This study explores the safety and efficacy of immunotherapy combined with definitive concurrent chemoradiotherapy for locally advanced ESCC. Method This study was an exploratory, open, single‐arm clinical trial involving 20 untreated patients with locally advanced ESCC. The patients were treated with eight cycles (4 weeks per cycle) of SHR‐1210 concurrently combined with 6 weeks of radiotherapy, and 4 weeks of chemotherapy and apatinib beginning from 4 weeks after the completion of radiotherapy to the end of treatment. Primary end‐points were treatment‐related adverse events, serious adverse events, and patients’ quality of life (European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (QLQ)‐C30 and QLQ‐OES18). Secondary end‐points were the objective response rate, progression‐free survival, and overall survival. Discussion This phase Ib study evaluates the tolerability and efficacy of programmed cell death‐1 antibody along with definitive concurrent chemoradiotherapy in treating locally advanced ESCC. This novel combination is expected to yield fewer side‐effects and better survival.