356
Participants
Start Date
May 1, 2024
Primary Completion Date
March 1, 2028
Study Completion Date
March 1, 2028
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."
RECRUITING
Ruijin hospital, Shanghai
Ruijin Hospital
OTHER