Consolidative Camrelizumab Following Definitive Concurrent Chemoradiation Therapy With Involved-Field Irradiation in Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial
Abstract
Purpose: Definitive concurrent chemoradiation therapy (dCCRT) is considered the standard treatment for locally advanced unresectable esophageal squamous cell carcinoma (ESCC). However, approximately half of the patients still experience local recurrence or distant metastasis. The CheckMate 577 trial, a phase III randomized clinical trial evaluating adjuvant nivolumab after neoadjuvant chemoradiotherapy and surgery, demonstrated that adjuvant nivolumab significantly improves disease-free survival in patients with resected esophageal or gastroesophageal junction cancer after neoadjuvant chemoradiation therapy. However, the role of consolidation immunotherapy in locally advanced unresectable esophageal cancer remains unclear. Camrelizumab, an anti-programmed death receptor 1 antibody, has shown antitumor activity in advanced or metastatic ESCC. We conducted a clinical trial to evaluate the efficacy of camrelizumab consolidation therapy in patients with unresectable, locally advanced ESCC following dCCRT.
Methods and materials: This single-arm, phase 2 trial was conducted at the Fourth Hospital of Hebei Medical University (Shijiazhuang, China). Eligible patients were aged 18 to 75 years with histopathologically confirmed, locally advanced (T1bN+M0, T2-4N0-2M0, or supraclavicular lymph node metastasis) unresectable or medically inoperable ESCC, who had not experienced disease progression after completing dCCRT. Patients received camrelizumab consolidation therapy (200 mg…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.
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