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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT05174156
Eligibility Criteria:
Inclusion Criteria:
* Unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
* Not received any previous systematic antitumor therapy.
* Eastern Cooperative Oncology Group (ECOG) fitness status score was 0 or 1 within 3 days before the first administration of the intervention.
* 8-10 tumor tissue samples can be provided.
* Demonstrate good organ and bone marrow function.
* Consent to participate in the contraceptive methods related to clinical research.
Exclusion Criteria:
* Have a history of allergy to monoclonal antibodies, any component of SHR-1210, albumin-paclitaxel, carboplatin, and other platinum drugs;
* Weight loss \> 20% in the past 3 months.
* Major surgery within 28 days prior to enrollment.
* Have received systemic chemotherapy or radiation therapy for esophageal cancer.
* Had a myocardial infarction within the past 6 months.
* Have any medical history or current evidence, treatment, or laboratory abnormalities that prevent the subject from participating fully in the study with the investigator's opinion.
* Prior treatment with immunotherapy drugs.
* Received live vaccine within 30 days prior to initial administration of the investigational drug.
* Have been diagnosed with immunodeficiency or are receiving immunosuppressive treatment.
* Another malignancy is known to exist.
* Have active infections that require systemic treatment.
* Pregnant or lactating, or planning to become pregnant or become a father during the study period (180 days for lactating subjects receiving carboplatin) from the beginning of the screening visit until 120 days after the last dose of the study intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05174156
Study Brief:
Protocol Section:
NCT05174156