An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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