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

Condition(s) studied

Investigational drug(s) / intervention(s)

Experimental: Arm 1 Organ preservation: 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

Active Comparator: Arm 2 Surgery: 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.

Study 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

Primary outcome measure(s)

• 3-year overall survival rate — From date of randomization until the date of death from any cause，up to 5 years
  The proportion of patients who survived within 3 years from randomization

Trial sites (1)

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