drugset / Trial / NCT04390958

Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

NCT04390958 ↗

Phase 2 Unknown 70 enrolled Chinese Academy of Medical Sciences
NaSingle-groupOpen-labelTreatment

Summary

Surgical resection is currently the major treatment for esophageal carcinoma while disease progression still occurred in most cases within 3 years. The rate of local recurrence and distant metastases could reach nearly 40% to 60%. The neoadjuvant chemotherapy could significantly improve resection rate and overall survival after surgery. Squamous cell carcinoma is the most common histology in Asia. JCOG9907 trial performed in Japan confirmed that compared to surgery plus adjuvant chemotherapy, the combination of neoadjuvant chemotherapy and surgery could further prolong overall survival. The regimen of cisplatin and fluorouracil is a classic effective option in combination therapy for esophageal carcinoma. Nanoparticle albumin-bound (nab)-paclitaxel is a novel taxane and has better efficacy in esophageal carcinoma treatment. We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin and capecitabine for locally advanced thoracic esophageal squamous cell carcinoma patients.

Timeline

Start
2020-05-15
Primary completion
2022-06
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1750 mg/m2 Oral
Subject Cisplatin Other / unclassified 60 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous