esophageal squamous cell carcinoma
Conditions
Interventions
Regime1:KN046 followed Chemoradiotherapy
Regime 2:Concurrent chemoradiotherpy and KN046
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects can understand the informed consent, volunteer to participate and sign the informed consent; 2. On the day the subject signs the informed consent, aged 18 to 75 years; 3. Histologically confirmed recurrent or metastatic esophageal squamous cell carcinoma; 4. According to the RECIST 1.1 standard, there is at least 1 measurable lesion at baseline; 5. ECOG 0 or 1; 6. Adequate function of liver, kidney and bone marrow.
Exclusion criteria
Exclusion criteria: 1. Untreated subjects with active brain metastases or meningeal metastases; 2. Participated in any other interventional clinical trials within 28 days before the study; 3. Received other anti-tumor treatments within 28 days before the study; 4. Underwent major surgical treatment within 28 days before the study; 5. Received radical radiation therapy within 3 months before the study; 6. Previously received immune checkpoint blockers or T-cell co-stimulation drugs; 7. Received systemic corticosteroids within 14 days before the study; 8. Received live vaccines (including live attenuated vaccines) within 28 days before the study; 9. Past or present history of interstitial pneumonia / pulmonary disease; 10. Past or present history of autoimmune disease; 11. Combined with other malignant tumors within 5 years before the first administration; 12. Suffering from uncontrolled comorbidities, including but not limited to the following: (1) active HBV or HCV infection; (2) Known history of HIV infection or AIDS; (3) active tuberculosis; (4) active infections; (5) uncontrolled hypertension; (6) severe heart disease; (7) active bleeding; 13. The toxicity of previous antitumor treatment has not returned to CTCAE <=Gr 1; 14. History of previous allogeneic bone marrow or organ transplant; 15. A history of allergic reactions and intolerance to antibody drugs; 16. Pregnant and / or breastfeeding women; 17. History of fistula or prone to fistula; 18. Severe malnutrition before randomization; 19. Conditions that may affect the safety or adherence in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DOR;PFSR-6m; | — |
Countries
China
Contacts
Public ContactQin Songbing
The First Affiliated Hospital of Soochow University
Outcome results
None listed