Esophageal cancer
Conditions
Interventions
Monotherapy with Atezolizumab (1200 mg), every 3 weeks intravenous administration
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria of primary part; 1. Histologically confirmed esophagus squamous cancer, adenosquamous cell carcinoma or basaloid-squamous carcinoma. 2. The primary lesion located within the thoracic esophagus 3. Diagnosed unresectable cancer with computed tomography (CT) scanned before the chemoradiotherapy (CRT) 4. No distant metastasis except supraclavicular lymph node with the CT before the CRT 5. No prior treatment for the esophageal cancer except endoscopic resection before CRT 6. Able to be enrolled to the study within 28 days after CRT that fulfills the requirements 7. Eligibility criteria of postoperative recurrence part: 1. Surgical specimen histologically diagnosed as esophagus squamous cancer, adenosquamous cell carcinoma or basaloid-squamous carcinoma. 2. Unresectable, locoregionally recurrent cancer that can be treated with definitive CRT after the curative surgery for the primary esophageal cancer 3. No distant metastasis except supraclavicular lymph node with the CT before CRT 4. 24 weeks or longer elapsed on the first day of CRT after adjuvant chemotherapy, if conducted 5. Able to be enrolled to the study within 28 days after CRT that fulfills the requirements 6. Common eligibility criteria 1. Age of 20 years or older 2. ECOG performance status of 0 or 1 3. Adequate hematologic and organ function 4. For women of childbearing potential: negative in a urine pregnancy test 5. Agreement to use an effective form of contraceptive methods from the consent through five months after the last dose of atezolizumab 6. Life expectancy of 3 months or longer 7. Singed informed consent form
Exclusion criteria
Exclusion criteria: 1. Active double cancers 2. Requiring systemic treatment for active infection 3. Past or concurrent inflammatory bowel disease 4. Past or concurrent interstitial lung disease 5. Concurrent autoimmune disease or past chronic or recurrent autoimmune disease 6. Requiring Systemic treatment with corticosteroids or immunosuppressants or who have received these treatments within 14 days before the enrollment in the study 7. Past or concurrent thyroid dysfunction 8. A history or finding of cardiovascular risk 9. Poorly controlled diabetes mellitus. 10. Positive for any of the followings: HIV antibody, HBs antigen, HCV antibody test. 11. Pregnant or lactating 12. Clinically significant unstable psychiatric disorders or other medical disorders 13. No prior treatment with atezolizumab, anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-CTLA-4 antibody, or any other antibody or drug therapy regulating T cell 14. Not willing to comply or incapable of complying with the procedures specified in the protocol. 15. Unsuitable for the study due to such as a complicated disorder affecting the assessment of toxicity in the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed complete response rate by investigators' assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Confirmed complete response rate by central assessment - Progression-free survival - Objective Response rate - Overall survival - Incidences of adverse events - Sites of progressive disease | — |
Countries
Japan
Contacts
Public ContactHideaki Bando
Aichi Cancer Center Hospital Department of Clinical Oncology
Outcome results
None listed