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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 18-75 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 18-75 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 Criteria: * 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.

Treatments Being Tested

DRUG

Immune 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