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

PHASE3RecruitingINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

March 1, 2028

Study Completion Date

March 1, 2028

Conditions
Esophageal Cancer
Interventions
COMBINATION_PRODUCT

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"

COMBINATION_PRODUCT

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."

Trial Locations (1)

Unknown

RECRUITING

Ruijin hospital, Shanghai

All Listed Sponsors
lead

Ruijin Hospital

OTHER