2249 - Consolidative Camrelizumab Following Definitive Concurrent Chemoradiotherapy In Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial
Presenter(s)
Y. Cheng1, J. Wang2, X. Lv3, and J. Wang1; 1Department of Radiation Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China, 2Fourth Hospital of Hebei Medical University, Shijiazhuang, China, 3Department of Radiation Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, China
Purpose/Objective(s): Definitive concurrent chemoradiotherapy (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 PACIFIC trial demonstrated that consolidation immunotherapy with durvalumab improves progression-free survival (PFS) and overall survival (OS)in patients with unresectable, stage III non-small cell lung cancer (NSCLC) after CCRT. However, the efficacy of consolidation immunotherapy in locally unresectable esophageal cancer still remains unclear. Camrelizumab as an anti–programmed death receptor 1 (PD-1) antibody, has shown antitumor activity in advanced or metastatic esophageal squamous cell carcinoma. We conducted a clinical trial to evaluate the efficacy of camrelizumab in patients with unresectable, locally advanced ESCC following dCCRT.
Materials/Methods: This single-arm, phase II trial was conducted at the Fourth Hospital of Hebei Medical University (Shijiazhuang, China). Eligible patients were aged 18-75 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 intravenously [iv], day 1, every 2 weeks [q2w]) for 12 months. After 12 months, patients could choose to continue immunotherapy or not independently. The primary endpoint was progression-free survival (PFS). Secondary endpoints included disease control rate (DCR), objective response rate (ORR), duration of response (DoR), overall survival (OS) and safety.
Results: Between April 2020 and November 2023, 43 patients were screened, 35 were enrolled, and 32 were included in the analysis. As of the data cut-off date (July 25, 2025), 12 patients had experienced disease progression, and 10 patients had died. The DCR was 59.4% (19/32). Neither the median PFS nor the median OS was reached. The 1-year, 2-year and 3-year PFS rate was 81.3%, 62.5% and 62.5%, respectively. The 1-year, 2-year and 3-year OS rate was 96.9%, 77.7% and 63.0%, respectively. Regarding safety, most AEs were grade 1-2. The most common AEs were anemia (68.8%), leukopenia (50.0%), and reactive cutaneous capillary endothelial proliferation (RCCEP) (43.8%). Grade 3 AEs included leukopenia (12.5%) and thrombocytopenia (3.1%). No treatment-related deaths occurred. The incidence of pneumonitis in the cohort was 31.3%; all cases were grade 1-2, with no grade =3 pneumonitis observed.
Conclusion: Consolidative camrelizumab following definitive concurrent chemoradiotherapy with IFI shows promising efficacy and manageable toxicity in patients with unresectable locally advanced ESCC.