drugset / Trial / NCT04644250

Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT04644250

Phase 2 Unknown 32 enrolled Wei Ren
NaSingle-groupOpen-labelTreatment

Summary

Radical resection is thought to be the mainstay of esophageal cancer treatment. Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal squamous cell cancer (ESCC). However, only 20% to 40% of patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis and about 10% of patients have disease progression after chemoradiotherapy. How to improve the the efficacy of neoadjuvant therapy is an important clinical problem to be solved. Immunotherapy targeting the programmed cell death receptor-1(PD-1) /programmed cell death-Ligand 1(PD-L1) checkpoints has demonstrated promising activity in ESCC. In Keynote181 study, for patients with metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression, pembrolizumab significantly improved overall survival compared with chemotherapy. However, the efficacy and safety of immunotherapy therapy in surgery-based multidisciplinary treatment of local advanced esophageal cancer still need a lot of clinical studies to further confirm. This study aims to investigate the safety and efficacy of Toripalimab combined with radiotherapy and chemotherapy in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma

Timeline

Start
2020-09-01
Primary completion
2022-03-01
Completion
2024-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule
Subject Paclitaxel liposome Unknown 50 mg/m2
Subject Toripalimab Monoclonal antibody 240 mg