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

Phase 3

Recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT06339060
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

The investigators will conduct the open, multicenter, prospective, randomized controlled clinical study(PALACE3). Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to either receive neoadjuvant synchronous radiotherapy and chemotherapy combined with immunotherapy followed by organ preservation strategy (experimental group, Arm1) or neoadjuvant concurrent radiotherapy and chemotherapy followed by radical surgery (control group,Arm 2). Collect relevant data on preoperative treatment, re examination after neoadjuvant therapy, perioperative and long-term follow-up of patients, and evaluate the clinical treatment effects (cCR rate), surgical pathological results (pCR rate, R0 resection rate, tumor regression grade, lymph node positivity rate), neoadjuvant therapy and perioperative complications, long-term oncological effects (total survival, disease-free survival), and quality of life of the two treatment plans through statistical analysis.

Study Timeline

• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-01
• Study Start: 2024-05-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03
• Primary Completion: 2028-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
3-year overall survival rate	From date of randomization until the date of death from any cause，up to 5 years	The proportion of patients who survived within 3 years from randomization

Trial Locations

Locations (1)

Ruijin hospital; 🇨🇳 Shanghai, China