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

Recruiting now · Phase 3

Conditions studied: Esophageal Cancer

In brief

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.

Key facts

Study ID

NCT06339060

Run by

Ruijin Hospital

People needed

356

Starts

2024-05-01

Expected to finish

2028-03-01

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ruijin hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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