Skip to content

Phase II exploratory study of radiotherapy combined with tislelizumab in the treatment of locally advanced esophageal squamous cell carcinoma

Phase II exploratory study of radiotherapy combined with tislelizumab in the treatment of locally advanced esophageal squamous cell carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053182
Enrollment
Unknown
Registered
2021-11-13
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-09-20

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 combined with tislelizumab

Sponsors

Binzhou Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histopathologically proven II-IVa cervical and thoracic esophageal squamous cell carcinoma (UICC 2002 stage); 2. ECOG 0-1; life expectancy > 6 months; 3. Aged 18-80 years, no gender limit; at least able to take liquid diet; 4. No chemotherapy or radiotherapy was used before selection; 5. No history of immunotherapy; 6. No surgical treatment; 7. No serious allergic history; 8. Hemoglobin>=100 g/L, WBC >= 3.5x10^9/L, neutrophil >= 1.5x10^9, platelet >= 100 x 10^9/L; CR <= 1.5x upper limit of normal, TB <= 2.5x upper limit of normal, AST and ALT <= 2.5x upper limit of normal, AKP <= 2.5x upper limit of normal; 9. Barium meal angiography lesion length 10cm; 10. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. History of malignant tumors in other parts; 2. Duplicate carcinoma of the esophagus; 3. Pregnant or lactating patients; 4. Fertility but not using contraceptive measures; 5. Serious comorbidities: very high risk hypertension, severe pulmonary function damage, massive myocardial infarction, cardiac function >= grade II, mental history and severe diabetes; 6. During the active period of infectious diseases; 7. Participate in other clinical trials at present or within four weeks before enrollment; 8. Treatment with other anticancer drugs at the same time (including anticancer traditional Chinese medicine); 9. After esophageal stent placement; 10. Patients with perforation tendency; 11. Have a history of organ transplantation; 12. History of allergy to monoclonal antibodies or uncontrolled allergic asthma; 13. Suffering from active autoimmune disease or a history of autoimmune disease; 14. Patients with a history of primary immunodeficiency; 15. Suffering from interstitial lung disease or non-infectious pneumonia requiring hormone therapy, or active tuberculosis; 16. Any drug that has received T cell co-stimulation or checkpoint pathway; 17. Received attenuated or vaccine within 28 days prior to administration.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Countries

China

Contacts

Public ContactNing Fangling

Binzhou Medical University Hospital

ningfangling@163.com+86 543 3258761

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026