drugset / Trial / NCT04625543

Neoadjuvant Immunotherapy to ESCC

NCT04625543 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Currently, surgery after neoadjuvant chemoradiotherapy is the standard treatment for patients with locally advanced esophageal cancer, but the recurrence rate is high and the 5-year survival rate is low. Immunotherapy shows a potential treatment for esophageal cancer. Immunocheckpoint (PD-1/PD-L1) inhibitors can activate tumor immunity. The guidelines have recommended it as a sencond-line therapy. However, there is still lack of the evidence for its efficacy as a neoadjuvant therapy. This study is to conduct a randomized controlled, open label, phase II clinical trial to evaluate the efficacy and safety of neoadjuvant immnotherapy combined with neoadjuvant chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC) patient with PD-L1 (CPS\>=10%) positive.

Timeline

Start
2020-12
Primary completion
2023-06
Completion
2023-09

Outcome

Outcome not reported

Stopped: “insufficient money”

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg —
Comparator Cisplatin Other / unclassified 70 mg/m2 —
Comparator Paclitaxel Small molecule 150 mg/m2 —