NCT06339060 An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3).
| NCT ID | NCT06339060 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ruijin Hospital |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 356 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 356 participants in total. It began in 2024-05-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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
Contact & Investigator
Hecheng Li, MD/PHD
PRINCIPAL INVESTIGATOR
Ruijin Hospital Shanghaijiaotong University School of Medicine
Frequently Asked Questions
Who can join the NCT06339060 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06339060 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 356 participants.
Is NCT06339060 currently recruiting?
Yes, NCT06339060 is actively recruiting participants. Contact the research team at lihecheng2000@hotmail.com for enrollment information.
Where is the NCT06339060 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06339060 clinical trial?
NCT06339060 is sponsored by Ruijin Hospital. The principal investigator is Hecheng Li, MD/PHD at Ruijin Hospital Shanghaijiaotong University School of Medicine. The trial plans to enroll 356 participants.
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