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Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

NCT04435197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2024-07-03

No results posted yet for this study

Summary

To investigate the safety and activity of preoperative pembrolizumab combined with chemoradiotherapy for resectable esophageal squamous cell carcinoma (ESCC) ,20 patients enrolled in Phase Ib PALACE-1(NCT03792347).The results showed that preoperative pembrolizumab with concurrent chemoradiotherapy was safe, did not delay surgery and induced a pCR in 55.6% of resected tumors. In this multicentre prospective study(PALACE-2),the investigators will evaluate the efficacy of preoperative pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

Conditions

Interventions

DRUG

Pembrolizumab Injection

Pre-operative Pembrolizumab+chemoradiotherapy

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Hecheng Li, MD&PHD · Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435197 on ClinicalTrials.gov