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:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT03927495
Eligibility Criteria:
Inclusion Criteria:
* Signed inform consent form(ICF)
* Age ≥ 18 years and ≤ 75 years, male or female
* Histologically or cytologically documented recurrent or metastatic esophageal squamous cell carcinoma, with indications of radiotherapy and without prior systemic treatment
* At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
* Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
* Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures
Exclusion Criteria:
* Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated.
* Patients who are participating or have participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
* Patients who have received immune checkpoint proteins/antibody/medicine for treatment.
* Patients who have interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
* Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded
* Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
* Known HIV infection or known history of acquired immune deficient syndrome (AIDS)
* Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia
* Patients who have serious hypersensitive reaction to monoclonal antibodies and have history of uncontrolled allergic asthma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03927495
Study Brief:
Protocol Section:
NCT03927495