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A multicenter, prospective, one-arm, real-world study of Tirelizumab combined with chemoradiotherapy for locally advanced esophageal squamous cell carcinoma

A multicenter, prospective, one-arm, real-world study of Tirelizumab combined with chemoradiotherapy for locally advanced esophageal squamous cell carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059190
Enrollment
Unknown
Registered
2022-04-26
Start date
2022-08-26
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

experimental group:Tislelizumab Injection

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, no gender limitation; 2. The ECOG score of the patient is 0 or 1; 3. Patients who have not received previous anti-tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy); 4. Histopathological diagnosis of locally advanced esophageal squamous cell carcinoma was II-IVa; 5. Clinical evaluation of patients with infeasible radical resection of esophageal cancer or rejection of surgery; 6. Plan to receive tirelizumab and radical radiotherapy and chemotherapy; 7. The expected treatment period of tirelizumab >=2; 8. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient had contraindications of immunotherapy and radical radiotherapy and chemotherapy; 2. Patients with high-risk esophageal perforation; 3. Patients planned to receive surgical treatment such as esophagectomy; 4. Patients with distant metastasis cannot be excluded clinically.

Design outcomes

Primary

MeasureTime frame
2-year overall survival;

Secondary

MeasureTime frame
objective response rate (ORR);progression-free survival (PFS);treatment-related adverse events (TRAE);immune-related adverse events (irAE);

Countries

China

Contacts

Public ContactCheng Yufeng

Qilu Hospital of Shandong University

qlcyf@163.com+86 18560081666

Outcome results

None listed

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