Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAnhui Provincial Hospital

About this trial

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 criteria

Qualifiers

18-75 years old.

After esophagectomy.

Confirmation of squamous cell carcinoma by pathological examination.

Pathological staging of pIIb-IVa.

Disqualifiers

Younger than 18 years old or older than 75 years old.

Without esophagectomy.

Non-squamous cell carcinoma.

Pathological staging of pI, IIa, IVb.

Trial design

Treatments tested in this trial

  • Immune Checkpoint Inhibitors

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

1
Anhui Provicial Hospital HefeiAnhui, China

Sponsors and collaborators

Anhui Provincial Hospital

Lead sponsor