Status:
UNKNOWN
An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Progression to PD-1 Antibody
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.
Eligibility Criteria
Inclusion
- Patients who were diagnosed as esophageal squamous cell carcinoma by histopathology with at least one measurable lesion according to RECIST 1.1 criteria.
- Must have had progressive disease after previous treatment with PD-1 inhibitor
- ECOG score 0-2
- The expected survival time is ≥ 12 weeks
- Previous permanent discontinuation did not occur due to adverse events associated with immunotherapy, or the immunotreatment-related adverse events recovered to ≤1 grade
Exclusion
- Had other active malignant tumors within 5 years before entering the study
- Had abnormal swallowing function or dysfunction of gastrointestinal absorption
- The first study drug treatment was less than 28 days or 5 half-lives (in terms of longer) from the last radiotherapy, chemotherapy, targeted therapy or immunotherapy
- Patients who have already received surgery within 28 days (biopsy for diagnosis is permitted)
- Pregnant or lactating women
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04866381
Start Date
April 1 2021
End Date
April 1 2023
Last Update
April 29 2021
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060