RecruitingPhase 2NCT06187597

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

Efficacy and Safety of Toripalimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma: a Multicenter, Randomized, Phase II Trial (EC-CRT-007)


Sponsor

Sun Yat-sen University

Enrollment

140 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 70 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study (EC-CRT-007) tests whether adding toripalimab (an immunotherapy drug) after completing chemoradiotherapy helps elderly patients with locally advanced esophageal squamous cell cancer live longer without the cancer coming back. **You may be eligible if...** - You are between 70 and 85 years old - You have locally advanced esophageal squamous cell carcinoma confirmed by biopsy - Your cancer has not spread to distant organs - You are not a candidate for surgery, or you have declined surgery - You have not previously received any cancer treatment - Your overall health is adequate (ECOG performance status 0–2) **You may NOT be eligible if...** - Your cancer has spread beyond local/regional areas (hematogenous metastasis) - You have already had prior cancer therapy - You have active autoimmune disease or are on immunosuppressive therapy - You are under 70 or over 85 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGS-1

Patients received S-1 administration, 70mg/m2 per day, orally on days 1 to 14 and 29 to 42 during radiotherapy.

DRUGToripalimab

Patients received toripalimab 240 mg every 3 weeks for up to 16 cycles.

RADIATIONIntensity-modulated radiotherapy

All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 54 Gy in 27 fractions over 5-6 weeks.


Locations(1)

Mian Xi

Guangzhou, Guangdong, China

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NCT06187597


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