Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Esophageal squamous cell carcinoma is a common malignancy in China. Although neoadjuvant chemoradiotherapy followed by esophagectomy remains a standard modality for locally advanced esophageal squamous cell carcinoma, esophagectomy followed by postoperative radiotherapy is also prevalent in China. Several retrospective studies demonstrated that postoperative radiotherapy could improve the prognosis of patients. Nevertheless, there still existed approximately 11.5% and 17.2% of total patients developing local-regional relapse and hematological metastasis. The result of Checkmate 577 has shown that postoperative immunotherapy of nivolumab could improve the disease-free survival (median Disease-free Survival 29.7 mos vs. 11.0 mos). Therefore, investigators aimed to implement a pilot study to explore the safety and efficacy of combining postoperative radiotherapy and immunotherapy for patients with locally advanced esophageal squamous cell carcinoma after esophagectomy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 18-75 years old.

• After esophagectomy.

• Confirmation of squamous cell carcinoma by pathological examination.

• Pathological staging of pIIb-IVa.

• Over 12 lymph nodes dissected during surgery.

• ECOG 0-1.

• Signature of inform consent by patients

Locations
Other Locations
China
Anhui Provicial Hospital
RECRUITING
Hefei
Contact Information
Primary
Dong Qian, M.D.
qiandong@ustc.edu.cn
+86-19156007756
Backup
Dong Qian, M.D.
qiandong@ustc.edu.cn
+8619156007756
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 70
Treatments
Experimental: Experimental Arm
Esophagectomy+postoperative radiotherapy+immunotherapy
Other: Controlled Arm
Esophagectomy+postoperative radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov