RecruitingPhase 1Phase 2NCT05937438

Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma

Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Study


Sponsor

Anhui Provincial Hospital

Enrollment

70 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Esophageal squamous cell carcinoma is a common malignancy in China. Although neoadjuvant chemoradiotherapy followed by esophagectomy remains a standard modality for locally advanced esophageal squamous cell carcinoma, esophagectomy followed by postoperative radiotherapy is also prevalent in China. Several retrospective studies demonstrated that postoperative radiotherapy could improve the prognosis of patients. Nevertheless, there still existed approximately 11.5% and 17.2% of total patients developing local-regional relapse and hematological metastasis. The result of Checkmate 577 has shown that postoperative immunotherapy of nivolumab could improve the disease-free survival (median Disease-free Survival 29.7 mos vs. 11.0 mos). Therefore, investigators aimed to implement a pilot study to explore the safety and efficacy of combining postoperative radiotherapy and immunotherapy for patients with locally advanced esophageal squamous cell carcinoma after esophagectomy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy after radiation therapy improves outcomes for people who had surgery for locally advanced esophageal (food pipe) cancer. **You may be eligible if...** - You are between 18 and 75 years old - You already had surgery to remove your esophagus (esophagectomy) - Your cancer was confirmed as squamous cell carcinoma (a specific type) by biopsy - Your cancer was at a moderately advanced to advanced stage (pIIb–IVa) - More than 12 lymph nodes were removed during surgery - You are in good general health (able to carry out daily activities) **You may NOT be eligible if...** - Your cancer was not squamous cell type - Your cancer was at an early or very late stage (pI, IIa, or IVb) - Fewer than 12 lymph nodes were removed during surgery - Your health status is poor (significantly limited daily activity) 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

DRUGImmune Checkpoint Inhibitors

Patients assigned to experimental arm would receive the maintenance treatment of immune checkpoint inhibitor (Tislelizumab or Camrelizumab) after postoperative radiotherapy for one year


Locations(1)

Anhui Provicial Hospital

Hefei, Anhui, China

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NCT05937438


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