Back to resultsSHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer
Primary Purpose
Advanced Esophageal Squamous Cell Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan liposome
SHR-1316
Fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Esophageal Squamous Cell Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
- No previous systemic anti-tumor treatment;
- Subjects must have at least one measurable tumor lesion per RECIST 1.1;
- ECOG: 0-1;
- Adequate organ and bone marrow function;
Exclusion Criteria:
- Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;
Prior therapy as follow:
- Anti-PD-1 or anti-PD-L1;
- Any experimental drugs within 4 weeks of the first dose of study medication;
- Received major operations or serious injuries within 4 weeks of the first dose of study medication;
- Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
- Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
- Subjects with any active autoimmune disease or history of autoimmune disease;
- Pregnancy or breast feeding;
Sites / Locations
- Cancer Institute and Hospital,Chinese Academy of Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Irinotecan liposome plus SHR1316 plus fluorouracil
Arm Description
Outcomes
Primary Outcome Measures
Duration of Progression-Free Survival (PFS)
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Secondary Outcome Measures
Disease Control Rate(DCR)
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Objective Response Rate(ORR)
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Overall Survival(OS)
OS is defined as the time from registration to death due to any cause, or censored at date last known alive.
Adverse Events(AE)
adverse events
Full Information
NCT ID
NCT03732508
First Posted
October 31, 2018
Last Updated
November 5, 2018
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03732508
Brief Title
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer
Official Title
SHR-1316, a Novel Anti-PD-L1 Antibody, in Combination With Irinotecan Liposome and Fluorouracil in Patients With Esophageal Squamous Cell Cancer: a Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Squamous Cell Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irinotecan liposome plus SHR1316 plus fluorouracil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Irinotecan liposome
Intervention Description
Irinotecan liposome intravenous infusion will be administered during the first day of treatment.
Intervention Type
Drug
Intervention Name(s)
SHR-1316
Intervention Description
SHR-1316 intravenous infusion will be administered during the first day of treatment.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
Fluorouracil intravenous infusion will be administered during the first day of treatment.
Primary Outcome Measure Information:
Title
Duration of Progression-Free Survival (PFS)
Description
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
approximately 22 months
Secondary Outcome Measure Information:
Title
Disease Control Rate(DCR)
Description
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
approximately 22 months
Title
Objective Response Rate(ORR)
Description
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
approximately 22 months
Title
Overall Survival(OS)
Description
OS is defined as the time from registration to death due to any cause, or censored at date last known alive.
Time Frame
approximately 22 months
Title
Adverse Events(AE)
Description
adverse events
Time Frame
approximately 22 months
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:
Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
No previous systemic anti-tumor treatment;
Subjects must have at least one measurable tumor lesion per RECIST 1.1;
ECOG: 0-1;
Adequate organ and bone marrow function;
Exclusion Criteria:
Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;
Prior therapy as follow:
Anti-PD-1 or anti-PD-L1;
Any experimental drugs within 4 weeks of the first dose of study medication;
Received major operations or serious injuries within 4 weeks of the first dose of study medication;
Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
Subjects with any active autoimmune disease or history of autoimmune disease;
Pregnancy or breast feeding;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Shi
Phone
+86-18036618733
Email
hrshifei@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Huang
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital,Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Huang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer
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