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A Phase Ⅱ Trials of Sintilimab as Consolidation Therapy After Radical Concurrent Chemoradiotherapy in Locally Advanced Unresectable ESCC

NCT04514835 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-08-25

No results posted yet for this study

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for Consolidation Therapy After Radical Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Conditions

Interventions

DRUG

Cisplatin+Capecitabine+Sintilimab

The first stage:concurrent chemoradiotherapy，cisplatin，25-30mg/m2 ivgtt d1;capecitabine,800mg/m2, bid d1-5，qw，5weeks;concurrent radiotherapy,1.8-2Gy/d，5d/W，50-50.4Gy. second stage:Sintilimab, 200mg,q3w, a total of 3 times，Each infusion lasted for 30-60 min until disease progression or intolerable toxicity, with a maximum duration of no more than 12 months.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Principal Investigators

  • Feng Wang · The First Affiliated Hospital of Zhengzhou University

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
2021-12-01
Primary Completion
2022-01-31
Completion
2023-01-31

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 NCT04514835 on ClinicalTrials.gov