Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT03165994
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years of age.
2. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or GE junction.
3. Surgically resectable (T1-3 Nx preferably by endoscopic ultrasound \[EUS\]). (Excluded: T1N0 tumors, cervical esophageal location, tumors invading the tracheobronchial tree or with fistula, distant disease that cannot be included in the radiation field or be resected at the time of esophagectomy).
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
5. Adequate hematological, renal, and hepatic parameters.
Exclusion Criteria:
1. Any history of or current hematologic malignancy.
2. History of a second primary cancer is allowed in the event the cancer is curatively resected and there is no evidence of recurrence/metastatic disease x 1 year. Subjects who have a history of cervical or breast carcinoma in situ, localized prostate cancer, adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder tumors \[Ta, Tis \& T1\] are also allowed.
3. Major surgery within 4 weeks of first dose of investigational product.
4. Prior or concurrent treatment with any anticancer agent for the same cancer diagnosis.
5. Prior exposure to any immuno-oncology agents, including CD40/PD-1/PD-L1/CTLA-4 inhibitors (if any ambiguity, should be discussed with study principal investigator).
6. History of bone marrow transplantation.
7. History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders.
8. Chronic steroid dependency (prednisone equivalent \> 10 mg/day). Any steroid use should be discontinued at least 2 weeks prior to initiation of study treatment.
9. Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose.
10. Known human immunodeficiency virus (HIV) infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03165994
Study Brief:
Protocol Section:
NCT03165994