drugset / Trial / NCT05777707

Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma

NCT05777707

Phase 1/2 Unknown 89 enrolled Beijing Friendship Hospital
NaSingle-groupOpen-labelTreatment

Summary

This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.

Timeline

Start
2020-10-29
Primary completion
2023-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Carboplatin Small molecule Intravenous
Subject Nedaplatin Small molecule Intravenous
Subject Paclitaxel Small molecule 300 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Subject Toripalimab Monoclonal antibody 200 mg Intravenous