An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy.
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Ruijin hospital
RECRUITING
Shanghai
Contact Information
Primary
Hecheng Li
lihecheng2000@hotmail.com
19121652450
Backup
Chengqiang Li
lcq12305@rjh.com.cn
13524282905
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 356
Treatments
Experimental: Arm1 Organ preservation
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 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.
Active_comparator: Arm 2 Surgery
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.~Oesophagectomy will be offered to patients without contraindication.Postoperative adjuvant therapy will follow the NCCN guideline.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital