An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3).

Summary

Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to receive neoadjuvant chemo-radiotherapy combined with immunotherapy post organ preservation strategy (experimental group) or neoadjuvant chemo-radiotherapy followed by surgery (control group). The 3-year overall survival rate is the primary outcome.

Eligibility

Inclusion Criteria:

* A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:

  * Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma.
  * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  * Patients approve and sign the informed consent

Exclusion Criteria:

* Patients with active autoimmune disease or history of autoimmune disease.
* Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
* Subjects with a history of symptomatic interstitial lung disease.
* History of allergy to study drug components.
* Women must not be pregnant or breast-feeding.
* Men with female partners (WOCBP) that are not willing to use contraception.
* Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.
* medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events

Conditions2

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