Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06339060

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

Led by Ruijin Hospital · Updated on 2024-07-03

356

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Active autoimmune disease or history of autoimmune disease
  • Condition requiring systemic treatment with corticosteroids or other immunosuppressive medications
  • History of symptomatic interstitial lung disease
  • Allergy to study drug components
  • Women who are pregnant or breast-feeding
  • Men with female partners of childbearing potential not willing to use contraception
  • Prior chemotherapy, radiotherapy, targeted therapy, or immune therapy for this or any other malignancy
  • Medical conditions that may make study drug administration hazardous or obscure toxicity or adverse event interpretation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ruijin hospital

Shanghai, China

Actively Recruiting

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Research Team

H

Hecheng Li

CONTACT

C

Chengqiang Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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