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

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

NCT ID: NCT06339060

Condition: Esophageal Cancer

Conditions: Official terms:
Esophageal Neoplasms

Conditions: Keywords:
Chemoradiotherapy
Immunotherapy
Organ preservation
Active surveillance

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Masking description: Randomize patients who meet the inclusion criteria Grouping, randomly assigned to the experimental group in a 1:1 ratio (organ preservation strategy after neoadjuvant chemotherapy combined with immunotherapy) And the control group (limited time for esophageal cancer radical surgery after neoadjuvant radiotherapy and chemotherapy)

Intervention:

Intervention type: Combination Product
Intervention name: Experimental: Arm 1 Organ preservation
Description: Arm 1 patients will undergo clinical response evaluations (CREs) after neoadjuvant therapy(A+B+C）, If cancer is detected, surgery will be performed. Patients with clinical complete response （cCR） are eligible for active surveillance where regular CREs are performed to detect regrowth of cancer.Postoperative adjuvant therapy will follow the NCCN guideline. A: Camrelizumab 200mg IV on days 1 and 22 B: Carboplatin (AUC=2) IV and Paclitaxel-albumin (50mg/m²) IV on day 1,8,15,22,29. C: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. A+B+C=Neoadjuvant therapy
Arm group label: Arm1 Organ preservation

Intervention type: Combination Product
Intervention name: Active Comparator: Arm 2 Surgery
Description: Arm 2 patients will undergo surgery after neoadjuvant therapy(B+C）.Postoperative adjuvant therapy will follow the NCCN guideline. B: Carboplatin (AUC=2) IV and Paclitaxel-albumin (50mg/m²) IV on day 1,8,15,22,29. C: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week.
Arm group label: Arm 2 Surgery

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ruijin hospital

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Chengqiang LI, MD/PHD

Phone: 19121652450

Contact backup:
Last name: Yuqin Cao, MD/PHD

Start date: May 1, 2024

Completion date: March 1, 2028

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06339060