Clinical trial NCT06339060: An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3).
Official title: An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Cancer
Keywords: Chemoradiotherapy
Immunotherapy
Organ preservation
Active surveillance
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3-year overall survival rate
timeFrame: From date of randomization until the date of death from any cause，up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
Study officials:
affiliation: Ruijin Hospital Shanghaijiaotong University School of Medicine
name: Hecheng Li, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: