Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

NCT04844385 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-02-09

No results posted yet for this study

Summary

This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

Conditions

Interventions

DRUG

Toripalimab

Toripalimab 240 mg, d1, Q3w for two cycles

DRUG

Paclitaxel-albumin

Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles

DRUG

Nedaplatin

Nedaplatin 75mg/m2, d1, Q3w for two cycles

RADIATION

radiation therapy at a total dose 60 Gy

Radiation therapy at a total dose 60 Gy

DRUG

Capecitabine

Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy

RADIATION

radiation therapy at a total dose 50 Gy

Radiation therapy at a total dose 50 Gy

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hui Liu, Professor · Sun yat-sen universtiy cancer center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-20
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • China

Study Locations

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Entities

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 NCT04844385 on ClinicalTrials.gov