Back to resultsAn Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
Primary Purpose
Esophageal Squamous Cell Carcinoma, Progression to PD-1 Antibody
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-6390
SHR-6390 + Camrelizumab (SHR-1210)
Camrelizumab (SHR-1210) + SHR-1020
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility 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
Sites / Locations
- Tianjin Medical University Cancer Institute and Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SHR-6390
SHR-6390 combined with Camrelizumab (SHR-1210)
Camrelizumab (SHR-1210) combined with SHR-1020
Arm Description
SHR-6390
SHR-6390 combined with Camrelizumab (SHR-1210)
Camrelizumab (SHR-1210) combined with SHR-1020
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression-Free-Survival
Progression-Free-Survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first.
Overall survival
Overall survival is defined as time from treatment start date to date of death from any cause. Patients alive at the time of analysis are censored at last contact date.
Subject safety
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Full Information
NCT ID
NCT04866381
First Posted
April 15, 2021
Last Updated
April 27, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04866381
Brief Title
An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
Official Title
An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Progression to PD-1 Antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-6390
Arm Type
Experimental
Arm Description
SHR-6390
Arm Title
SHR-6390 combined with Camrelizumab (SHR-1210)
Arm Type
Experimental
Arm Description
SHR-6390 combined with Camrelizumab (SHR-1210)
Arm Title
Camrelizumab (SHR-1210) combined with SHR-1020
Arm Type
Experimental
Arm Description
Camrelizumab (SHR-1210) combined with SHR-1020
Intervention Type
Drug
Intervention Name(s)
SHR-6390
Intervention Description
SHR-6390
Intervention Type
Drug
Intervention Name(s)
SHR-6390 + Camrelizumab (SHR-1210)
Intervention Description
SHR-6390 combined with Camrelizumab (SHR-1210)
Intervention Type
Drug
Intervention Name(s)
Camrelizumab (SHR-1210) + SHR-1020
Intervention Description
Camrelizumab (SHR-1210) combined with SHR-1020
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-Free-Survival
Description
Progression-Free-Survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first.
Time Frame
Up to 1 year
Title
Overall survival
Description
Overall survival is defined as time from treatment start date to date of death from any cause. Patients alive at the time of analysis are censored at last contact date.
Time Frame
Up to 1 year
Title
Subject safety
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingsong Pang, MD
Phone
+86-22-23340123-1121
Email
pangqingsong@tjmuch.com
First Name & Middle Initial & Last Name & Degree
Ting Deng, MD
Phone
+86-22-23340123-1051
Email
xymcdengting@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
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