Esophageal squamous cell carcinoma
Conditions
Interventions
Experiment Group:tiralizumab combined with neoadjuvant chemoradiotherapy
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be able to provide written informed consent, and understand and agree to follow the research requirements and evaluation schedule; 2. Aged 18 to 75 years old; 3. Pathologically diagnosed patients with esophageal squamous cell carcinoma, and the clinical stage is stage II; 4. The newly treated patient, who has not undergone surgery in the past; 5. ECOG score: 0-2 points; 6. Expected survival >= 3 months; 7. All patients should have a measurable or assessable target lesion; 8. Able to eat a liquid diet above, no pre-esophageal perforation signs; 9. Major organspferforms normal, that is, the following criteria are met: (1) The criteria for blood routine examination must be met (no blood transfusions and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulators): 1) HB >= 100 g/L; 2) ANC >= 1.5 x 10^9/L; 3) PLT >= 100 x 10^9/L; (2) Biochemical examination must meet the following criteria: 1) TBIL 50 ml/min (Cockcroft-Gault formula) (3) Lung function: FEV >= 1L or > 50% of the estimated value; 10. Women during childbearing should be guaranteed contraception during the period of entry into the study; 11. Subjects voluntarily joined the study, and with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Not suitable for receiving any of the two-agent chemotherapy specified in the regimen; 2. Have previously received any treatment for esophageal squamous cell carcinoma; 3. Patients with evidence of fistula (esophagus/bronchus or esophagus/aorta); 4. Previous treatment with PD-1, PD-L1, or PD-L2 as a target; 5. Patients with active autoimmune diseases or a history of autoimmune diseases but possible recurrence. Remarks: Patients with the following disorders are not excluded and can be further screened: (1) Controlled type 1 diabetes mellitus; (2) Hypothyroidism (if controlled with hormone replacement therapy alone); (3) Controlled celiac disease; (4) Skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, hair loss); (5) Any other disease that is not expected to recur if there are no external triggers; 6. Any active malignancy = 160 mmHg or diastolic blood pressure >= 10
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Disease Control Rate, DCR;Quality of Life;Safety;Tumor markers; | — |
Countries
China
Contacts
Public ContactMa Hongbing
the Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed