drugset / Trial / NCT04937673

The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

NCT04937673

Phase 2 Unknown 40 enrolled Peking University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open, two arm phase II clinical study. 40 patients are included in the exploratory study. The dominant population with higher biomarker positive / IO score was identified to provide the basis for the later phase III study. The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. The treatment cycle was every 3 weeks. The curative effect was evaluated when the treatment cycle was 2, and the resection of esophageal cancer was considered after 3 cycles. Postoperative adjuvant therapy was based on the patient's condition and surgical results; For patients with R0 resection, postoperative adjuvant treatment is not recommended. For patients with R1 / R2 resection, multi-disciplinary joint discussion and consultation are recommended to propose individualized comprehensive treatment.

Timeline

Start
2021-07-01
Primary completion
2022-09-01
Completion
2022-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 130 mg/m2 Intravenous
Background Camrelizumab Monoclonal antibody 200 mg Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous