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

NCT06764355 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

  • ESCC
  • Total Neoadjuvant Treatment
  • Pathological Complete Response

Interventions

DRUG

Tislelizumab

200 mg, 1h-IVF, Q3W on day 1 for 2 cycles

DRUG

Paclitaxel

Paclitaxel 175 mg/m2, 3h-IVF, Q3W on day 1 for 2 cycles

DRUG

Cisplatin

Cisplatin 75 mg/m2, 2h-IVF, Q3W on day 1 for 2 cycles

RADIATION

Chemoradiotherapy

Chemoradiotherapy * Paclitaxel 50 mg/m2, 1h-IVF, on days 1, 8,15, 22, and 29; * Cisplatin 30 mg/m2,1h-IVF, on days 1, 8,15, 22, and 29; * RT: 1.8 Gy/fraction, 5 days a week, for 25 fractions (total dose= 45 Gy).

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

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
2025-07-23
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT06764355 on ClinicalTrials.gov