Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma
Recruiting now · Phase 1/Phase 2
Conditions studied: Esophageal Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05937438
- Run by
- Anhui Provincial Hospital
- People needed
- 70
- Starts
- 2023-09-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-01-29
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Younger than 18 years old or older than 75 years old.
- Without esophagectomy.
- Non-squamous cell carcinoma.
- Pathological staging of pI, IIa, IVb.
- Less than 12 lymph nodes dissected during surgery.
- ECOG 2-3 g. no signature of inform consent.
Where it is running
- Anhui Provicial Hospital — Hefei, Anhui, China (enrolling)
Full record on ClinicalTrials.gov
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