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Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma

Total Neoadjuvant Therapy With Induction Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT06764355•National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

Effective systemic therapy such as nivolumab as an adjuvant therapy has been demonstrated to improve the outcomes of patients receiving neoadjuvant chemoradiotherapy (CRT) for locoregional esophageal cancer. A more effective systemic therapy with anti-PD-1 or anti-PD-L1 immune checkpoint inhibitors (ICIs) plus cisplatin-based doublet chemotherapy, which has shown with high tumor response rate and improved survivals in patients with late-stage ESCC, may provide crucial benefit to patients with locally advanced disease by improving the systemic control, downstaging the locoregional tumor burden and reducing recurrence and metastasis. Collectively, the investigators hypothesize that total neoadjuvant therapy (TNT) approach-consisting of induction immunochemotherapy followed by CRT-is a promising strategy to enhance the outcomes for participants with locally advanced esophageal squamous cell carcinoma.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.
•2. Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition), fulfilling one of the following criteria as determined by staging procedures (including but not limited to endoscopic ultrasound, computed tomography, bronchoscopy or positron emission tomography):
•1. cT3/4a, N0, M0;
•2. cT1-4a, N1-3, M0.
•3. Tumor length longitudinal ≤ 10cm and radial ≤ 5cm.
•4. The tumor must not extend more than 2cm into the stomach.
•5. No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
•6. Age ≥ 18 and ≤ 75 years old.
•7. Performance status ECOG 0\~1.
•8. Adequate bone marrow reserves, defined as:
+12 more criteria

Exclusion Criteria

•1. Adenocarcinoma
•2. Previous thoracic irradiation
•3. Previous systemic chemotherapy
•4. Has received prior therapy with an anti-PD-1 or anti-PD-L1
•5. Synchronous diagnosis of squamous cell carcinoma in the aerodigestive tract, other than esophageal cancer.
•6. Prior malignancy, except for the following:
•1. adequately treated basal cell or squamous cell skin cancer;
•2. in-situ cervical cancer;
•3. a "cured" malignancy more than 5 years prior to enrollment.
•7. Significant co-morbid disease, which prohibits the conduction of immunochemotherapy, concurrent CRT, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
+16 more criteria

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Key Dates

Start Date

July 23, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2028

Last Updated

January 27, 2026

Enrollment

ESTIMATED participants

Conditions

ESCCTotal Neoadjuvant TreatmentPathological Complete Response

Interventions

Tislelizumab

DRUG

Paclitaxel

DRUG

Cisplatin

DRUG

Chemoradiotherapy

RADIATION

Contacts

Chih-Hung Hsu, M.D., PhD

CONTACT

+886-2-23123456 chihhunghsu@ntu.edu.tw

Chien-Huai Chuang, M.D.

CONTACT

+886-972652955 chuang.chienhuai@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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