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

NCT06187597 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

DRUG

S-1

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

DRUG

Toripalimab

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

RADIATION

Intensity-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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Zhujiang Hospital

    collaborator OTHER

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Wuhan University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Mian Xi, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06187597 on ClinicalTrials.gov