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Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma

NCT07039162 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-02-27

No results posted yet for this study

Summary

This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery.

The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)
  • Locally Advanced Unresectable Esophageal Cancer

Interventions

DRUG

Tislelizumab

1. ICRT phase -Tislelizumab and CRT regimen Tislelizumab 200 mg IV, C1D1 and C4D1 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. ) 3. Adjuvant phase-Tislelizumab Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of one year or 17 cycles.)

DRUG

Paclitaxel

1. ICRT phase -Tislelizumab and CRT regimen Paclitaxel 50 mg/m2 IV, D1, weekly (\* 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Paclitaxel 135 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles.)

DRUG

Cisplatin

1. ICRT phase -Tislelizumab and CRT regimen Cisplatin 25 mg/m2 IV, D1, weekly ( 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Cisplatin 75 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. )

RADIATION

Radiation Therapy

1\. ICRT phase -Tislelizumab and CRT regimen Radiotherapy treatment: IMRT 41-50.4Gy, a dose of 1.8 to 2Gy per day, 5 days per week for 5 weeks during the RT phase.

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Ming-Yu Lien

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT07039162 on ClinicalTrials.gov