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Exploring the Safety and Effectiveness of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Locally Advanced Esophageal Squamous Cell Carcinoma

NCT04888403 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-08-23

No results posted yet for this study

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Locally and Advanced Esophageal Squamous Cell Carcinoma

Conditions

  • Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Toripalimab+Nedaplatin+Albumin Paclitaxel

Toripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 1 cycles. Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel Neoadjuvant radiotherapy after 2W: The radiotherapy dose is 41.4Gy, completed in 23 times, 5 times a week, using intensity-modulated radiotherapy (IMRT) or volume-modulated radiotherapy (VMAT); In the same period, albumin paclitaxel combined with nedaplatin chemotherapy: albumin paclitaxel 60mg/m2 + nedaplatin 25mg/m2, performed once a week, 5 times in total; Simultaneous immunotherapy: 240 mg of Toripalimab (PD-1 antibody), once every 3 weeks, 4 times in total; Received radical resection of esophageal cancer within 7 weeks after radiotherapy and chemotherapy. Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel

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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-07-20
Completion
2022-07-20

Countries

  • China

Study Locations

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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 NCT04888403 on ClinicalTrials.gov