Back to resultsStudy of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer
Primary Purpose
Advanced Esophageal Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR-1210
Placebo
paclitaxel
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Esophageal Cancer focused on measuring PD-1Antibody, advanced esophageal cancer, paclitaxel, cisplatin
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;
- Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
- ECOG: 0-1;
- Adequate organ and bone marrow function;
Exclusion Criteria:
- Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
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 Center of Sun-Yat Sen University (CCSYSU)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SHR-1210 + paclitaxel + cisplatin
placebo+paclitaxel + cisplatin
Arm Description
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance
Outcomes
Primary Outcome Measures
PFS assessed by IRC
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
OS
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
Secondary Outcome Measures
PFS assessed by investigators
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
6 and 9 month OS rate
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
ORR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
DCR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
DoR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
AE
adverse events
Full Information
NCT ID
NCT03691090
First Posted
September 21, 2018
Last Updated
December 5, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03691090
Brief Title
Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer
Official Title
PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
April 30, 2022 (Actual)
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
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Detailed Description
In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Cancer
Keywords
PD-1Antibody, advanced esophageal cancer, paclitaxel, cisplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
596 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR-1210 + paclitaxel + cisplatin
Arm Type
Experimental
Arm Description
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance
Arm Title
placebo+paclitaxel + cisplatin
Arm Type
Active Comparator
Arm Description
Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Other Intervention Name(s)
camrelizumab
Intervention Description
SHR-1210 200mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
paclitaxel 175mg/m2
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
cisplatin 75mg/m2
Primary Outcome Measure Information:
Title
PFS assessed by IRC
Description
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
approximately 22 months
Title
OS
Description
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
Time Frame
approximately 22 months
Secondary Outcome Measure Information:
Title
PFS assessed by investigators
Description
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
approximately 22 months
Title
6 and 9 month OS rate
Description
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
Time Frame
approximately 6 and 9 months
Title
ORR
Description
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
approximately 22 months
Title
DCR
Description
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
approximately 22 months
Title
DoR
Description
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
approximately 22 months
Title
AE
Description
adverse events
Time Frame
approximately 22 months
Other Pre-specified Outcome Measures:
Title
Antidrug Antibodies (ADAs)
Description
To evaluate the incidence of ADAs against SHR-1210
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;
Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
ECOG: 0-1;
Adequate organ and bone marrow function;
Exclusion Criteria:
Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu
Organizational Affiliation
Cancer Center of Sun-Yat Sen University (CCSYSU)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qing Yang
Organizational Affiliation
Jiangsu HengRui Medicine Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Center of Sun-Yat Sen University (CCSYSU)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34519801
Citation
Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.
Results Reference
derived
Learn more about this trial
Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer
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