NCT05777707

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Carcinoma
• Neoadjuvant Immunotherapy

Interventions

Type	Name	Description
DRUG	PD-1 blockade	PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.
DRUG	Albumin paclitaxel	Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.
DRUG	Carboplatin/Nedaplatin	Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.

Timeline

• Start date: 2020-10-29
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2023-03-21
• Last updated: 2023-03-21

Locations

1 site across 1 country: China