Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT05937438

Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma

Led by Anhui Provincial Hospital · Updated on 2025-01-29

70

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 75 years old
  • Have had esophagectomy surgery
  • Confirmed diagnosis of esophageal squamous cell carcinoma by pathology
  • Pathological cancer stage between pIIb and IVa
  • More than 12 lymph nodes removed during surgery
  • ECOG performance status of 0 or 1
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Younger than 18 or older than 75 years old
  • Have not had esophagectomy surgery
  • Diagnosis of non-squamous cell carcinoma
  • Pathological cancer stage of pI, IIa, or IVb
  • Fewer than 12 lymph nodes removed during surgery
  • ECOG performance status of 2 or 3
  • Did not sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Anhui Provicial Hospital

Hefei, Anhui, China

Actively Recruiting

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Research Team

D

Dong Qian, M.D.

CONTACT

D

Dong Qian, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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