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

Inclusion Criteria7

  • years old.
  • After esophagectomy.
  • Confirmation of squamous cell carcinoma by pathological examination.
  • Pathological staging of pIIb-IVa.
  • Over 12 lymph nodes dissected during surgery.
  • ECOG 0-1.
  • Signature of inform consent by patients

Exclusion Criteria6

  • Younger than 18 years old or older than 75 years old.
  • Without esophagectomy.
  • Non-squamous cell carcinoma.
  • Pathological staging of pI, IIa, IVb.
  • Less than 12 lymph nodes dissected during surgery.
  • ECOG 2-3 g. no signature of inform consent.

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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