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A Study on the Efficacy and Safety of Sequential Maintenance Therapy with Tislelizumab Following Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

A Study on the Efficacy and Safety of Sequential Maintenance Therapy with Tislelizumab Following Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116088
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Observation Group:None

Sponsors

Meishan City Peoples Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis: Confirmed esophageal squamous cell carcinoma by gastroscopic biopsy or puncture biopsy (AJCC 8th edition T1b-4aN0-3M0); 2. Treatment history: Completed concurrent chemoradiotherapy (radiotherapy >=50.4 Gy, including >=2 cycles of platinum-based doublet chemotherapy), with radiotherapy using IMRT/VMAT technique (lung V20 =60 mL/min)

Exclusion criteria

Exclusion criteria: 1.Histological non-squamous subtypes(e.g., adenocarcinoma, neuroendocrine carcinoma); 2.Active autoimmune diseases(e.g., systemic lupus erythematosus [SLE], myasthenia gravis, Guillain-Barré syndrome); 3.Uncontrolled cardiopulmonary diseases, active infections, or other life-threatening conditions; 4.Severe complications after dCCRT, including radiation pneumonitis (=Grade 2) or gastrointestinal perforation; 5.Baseline ANA positivity or IL-6 >15 pg/mL(identifying high-risk groups for immune-related adverse events, irAEs); 6.Patients unable to undergo efficacy evaluation.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate (ORR);Adverse Reaction Incidence Rate;Disease Control Rate (DCR);

Secondary

MeasureTime frame
Safety Analysis (per CTCAE v5.0);

Countries

China

Contacts

Public ContactYingqing Liu

Meishan City Peoples Hospital

jack2005ms@163.com+86 28 38226319

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026