Neoadjuvant Immunotherapy to ESCC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sintilimab | Monoclonal antibody | 200 mg | — |
| Comparator | Cisplatin | Other / unclassified | 70 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 150 mg/m2 | — |