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NCT06187597: EC-CRT-007

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

Recruiting now Phase 2 Last updated 12 March 2024
What this trial tests

Phase 2 trial testing S-1 in Locally Advanced Esophageal Squamous Cell Carcinoma in 140 participants. Currently enrolling.

Timeline
1 March 2024
Primary endpoint
31 December 2026
31 December 2028

Quick facts

Lead sponsorSun Yat-sen University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment140
Start date1 March 2024
Primary completion31 December 2026
Estimated completion31 December 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-sen University

Who can join

Adults 70 to 85, any sex, with Locally Advanced Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of S-1

Trials testing the same drug.

Other recruiting trials for Locally Advanced Esophageal Squamous Cell Carcinoma

Currently open trials in the same condition.

Other Sun Yat-sen University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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