Last updated: July 7, 2022
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Squamous Cell Carcinoma
Esophageal Cancer
Esophageal Disorders
Treatment
N/AClinical Study ID
NCT05449483
E20220333A
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed esophageal squamous cell carcinoma;
- Unresectable cT4a/N3(stage ⅣA) (AJCC 8 TNM classification);
- Have a performance status of 0 or 1 on the ECOG Performance Scale;
- Age 18-75 years old, both men and women;
- Be willing and able to provide written informed consent/assent for the trial;
- Demonstrate adequate organ function, all screening labs should be performed within 10days of treatment initiation;
- Female subjects of childbearing potential should have a negative urine or serumpregnancy within 72 hours before receiving the study medication's first dose. If theurine test is positive or cannot be confirmed as unfavorable, a serum pregnancy testwill be required;
- Be willing to provide tissue from a newly obtained core or excisional biopsy of atumor lesion through repeated biopsies. Newly acquired is defined as a specimenobtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjectsfor whom newly-obtained samples cannot be provided (e.g. inaccessible or subjectsafety concern) may submit an archived specimen only upon agreement from the Sponsor.
Exclusion
Exclusion Criteria:
- Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophagealcancer;
- Ineligibility or contraindication for esophagectomy;
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form ofimmunosuppressive therapy within 7 days prior to the first dose of study drug;
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressivedrugs);
- Has severe hypersensitivity and adverse events (≥Grade 3) to any PD-1/PD-L1inhibitors.
Study Design
Total Participants: 40
Study Start date:
May 11, 2022
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Hongjing Jiang
Tianjin, Tianjin 300060
ChinaActive - Recruiting

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