Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)
Status:
Recruiting
Trial end date:
2028-12-31
Target enrollment:
Participant gender:
Summary
Although definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable
locally advanced esophageal cancer, elderly patients tolerate intravenous concurrent CRT less
well with age and comorbidities. Previous trials have demonstrated that CRT with oral S-1 was
tolerable and provided significant survival benefits over radiotherapy alone in elderly
patients with esophageal squamous cell carcinoma (ESCC). However, as high as 54% of patients
with elderly ESCC experienced locoregional or distant recurrence after CRT. Therefore, a more
effective regimen for older patients is needed. Immune checkpoint inhibitors targeting
PD-1/PD-L1 have shown substantial clinical benefits in advanced esophageal cancer. Recently,
the combination of immunotherapy with CRT has emerged as a promising strategy to improve
clinical outcomes in locally advanced esophageal cancer. The aim of this study was to
evaluate the efficacy and safety of toripalimab (an anti-PD-1 antibody) after concurrent CRT
in elderly patients with locally advanced ESCC.
Phase:
Phase 2
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Fifth Affiliated Hospital, Sun Yat-Sen University Nanfang Hospital, Southern Medical University Wuhan University Xiangya Hospital of Central South University Zhujiang Hospital