An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 15, 2021
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedApril 29, 2021
April 1, 2021
2 years
April 15, 2021
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
Objective Response Rate is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria.
1 year
Secondary Outcomes (3)
Progression-Free-Survival
Up to 1 year
Overall survival
Up to 1 year
Subject safety
Up to 1 year
Study Arms (3)
SHR-6390
EXPERIMENTALSHR-6390
SHR-6390 combined with Camrelizumab (SHR-1210)
EXPERIMENTALSHR-6390 combined with Camrelizumab (SHR-1210)
Camrelizumab (SHR-1210) combined with SHR-1020
EXPERIMENTALCamrelizumab (SHR-1210) combined with SHR-1020
Interventions
SHR-6390 combined with Camrelizumab (SHR-1210)
Camrelizumab (SHR-1210) combined with SHR-1020
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2021
First Posted
April 29, 2021
Study Start
April 1, 2021
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
April 29, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share