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Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

NCT04848753 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 663

Last updated 2026-04-08

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

Conditions

  • Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Interventions

COMBINATION_PRODUCT

Toripalimab combined with cisplatin and paclitaxel

Specified doses on specified days.

COMBINATION_PRODUCT

Placebo combined with cisplatin and paclitaxel

Specified doses on specified days.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Principal Investigators

  • Lin Shen · Peking University Cancer Hospital & Institute

  • Yongtao Han · Sichuan Cancer Hospital and Research Institute

  • Yan Zheng · Henan Cancer Hospital

  • Keneng Chen · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2027-05-12
Completion
2027-05-12

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 NCT04848753 on ClinicalTrials.gov