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A prospective, multicenter, one-arm phase II study of tislelizumab in combination with synchronous involvement wild (60Gy) chemotherapy for locally advanced unresectable esophageal squamous cell carcinoma

A prospective, multicenter, one-arm phase II study of tislelizumab in combination with synchronous involvement wild (60Gy) chemotherapy for locally advanced unresectable esophageal squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071208
Enrollment
Unknown
Registered
2023-05-08
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Esophageal squamous cell carcinoma

Interventions

Experimental group:radiotherapy + tislelizumab

Sponsors

Department of Thoracic Oncology, the Second Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Eastern Cooperative Oncology Group (ECOG) score =80 points; 2. Aged 18-75 years; 3. Esophageal squamous cell carcinoma was confirmed by histopathology; 4. American Joint Committee (AJCC) Edition 8 TNM patients with locally advanced (II-IVA) stage inoperable (including patients refusing surgery); 5. No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency, normal organ and bone marrow function; 6. No matter the status of PD-1/PD-L1; 7. Expected survival > 3 months; 8. There is no primary tumor in other sites before treatment or there is primary tumor in other sites but it has been controlled for more than 5 years; 9. Less than 2 cycles of previous chemotherapy; 10. Have not received radiotherapy, targeted therapy or immunotherapy.

Exclusion criteria

Exclusion criteria: 1. Patients with poor general condition who cannot tolerate chemotherapy; 2. The esophagus is completely obstructed and cannot take fluids; 3. Patients with a history of esophageal cancer surgery or high risk of fistula, perforation and bleeding due to primary tumor invasion; 4. Participate in other clinical trials; 5. Have interstitial pneumonia or previous history of interstitial pneumonia; 6. Have received radiation therapy in the planned radiotherapy area; 7. Distant metastasis has occurred.

Design outcomes

Primary

MeasureTime frame
Objective response rate;Safety;

Secondary

MeasureTime frame
Progression-free survival;Recurrence free survival;Overall survival;

Countries

China

Contacts

Public ContactHu Wei

The Second Affiliated Hospital of Zunyi Medical University

wayne551981@hotmail.com+86 1351183169

Outcome results

None listed

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