Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70-85
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

Histologically confirmed squamous cell carcinoma of the esophagus;

Locally advanced, and absence of hematogenous metastasis disease according to UICC TNM version 8;

Not suitable for surgery (either for medical reasons or patient's choice);

Age at diagnosis 70 to 85 years;

Disqualifiers

Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);

Patients with hematogenous metastasis disease or esophageal fistula at diagnosis;

Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin;

Patients who have a preexisting or coexisting bleeding disorder;

Trial design

Treatments tested in this trial

  • S-1
  • Toripalimab
  • Intensity-modulated radiotherapy

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Nanfang Hospital, Southern Medical University

Collaborator

Zhujiang Hospital

Collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

Xiangya Hospital of Central South University

Collaborator

Wuhan University

Collaborator