An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3).
Recruiting
Phase 3
Interventional Study
Esophageal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 356 (estimated)
- Sponsor
- Ruijin Hospital · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 a…
Contacts