Back to resultsA Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer
Primary Purpose
Gastric Cancer, GastroEsophageal Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210
Capecitabine
Oxaliplatin
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring PD-1, SHR-1210, Capecitabine, Oxaliplatin, Apatinib
Eligibility Criteria
Inclusion Criteria:
- Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ)
- Age ≥ 18 years old, male or female
- NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
- Has measurable disease per RECIST 1.1
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Group (ECOG) performance status of 0 to 1
- Has adequate organ function
- Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
Exclusion Criteria:
- Has known HER2-positive status
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
- Has known active central nervous system metastases.
- Has received a live vaccine within 4 weeks prior to the first dose of study treatment
- With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
- Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
- Coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical University
- Beijing Cancer Hospital
- The sixth affliated hospital of Sun Yat-Sen Unversity
- Harbin Tumor Hospital
- The First Affiliated Hospital of Zhengzhou University
- Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
- Nanjing Drum Tower Hospital
- Jilin Cancer Hospital
- The First Affiliated Hospital of Xi'an Jiaotong University
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m^2, IV q3w; for 4-6 cycles followed by SHR-1210 plus apatinib 375 mg PO qd.
Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus apatinib 375 mg daily (QD) continous oral. Study treatment will be started on Day 1 of each 3-week cycle.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Secondary Outcome Measures
Progression-free Survival (PFS) per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Duration of Response (DOR) per RECIST 1.1
For participants who demonstrate CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), DOR is defined as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1 based on assessments by blinded independent central review or death due to any cause, whichever occurs first.
Disease Control Rate (DCR) per RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Full Information
NCT ID
NCT03472365
First Posted
March 14, 2018
Last Updated
January 4, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03472365
Brief Title
A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer
Official Title
A Randomized Phase 2 Study to Evaluate Safety and Efficacy of the Combination of SHR-1210 With Capecitabine + Oxaliplatin or Apatinib as First-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
November 25, 2020 (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
The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Detailed Description
Approximately 110 participants will be assigned to SHR-1210 + capecitabine + oxaliplatin combination therapy (Cohort 1), or SHR-1210 + apatinib combination therapy (Cohort 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, GastroEsophageal Cancer
Keywords
PD-1, SHR-1210, Capecitabine, Oxaliplatin, Apatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m^2, IV q3w; for 4-6 cycles followed by SHR-1210 plus apatinib 375 mg PO qd.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus apatinib 375 mg daily (QD) continous oral. Study treatment will be started on Day 1 of each 3-week cycle.
Intervention Type
Biological
Intervention Name(s)
SHR-1210
Other Intervention Name(s)
Camrelizumab
Intervention Description
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000 mg/m^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
375 mg administered as continuous oral once daily (QD) of each 3-week cycle.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time Frame
Up to approximately 6 months.
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) per RECIST 1.1
Description
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Time Frame
Up to 24 months.
Title
Duration of Response (DOR) per RECIST 1.1
Description
For participants who demonstrate CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), DOR is defined as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1 based on assessments by blinded independent central review or death due to any cause, whichever occurs first.
Time Frame
Up to 24 months.
Title
Disease Control Rate (DCR) per RECIST 1.1
Description
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Time Frame
Up to 24 months.
Title
Number of Subjects with treatment-related adverse events (AEs)
Description
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Time Frame
Up to 24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ)
Age ≥ 18 years old, male or female
NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
Has measurable disease per RECIST 1.1
Life expectancy ≥ 12 weeks
Eastern Cooperative Group (ECOG) performance status of 0 to 1
Has adequate organ function
Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
Exclusion Criteria:
Has known HER2-positive status
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
Has known active central nervous system metastases.
Has received a live vaccine within 4 weeks prior to the first dose of study treatment
With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.
Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
Coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The sixth affliated hospital of Sun Yat-Sen Unversity
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Harbin Tumor Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33766817
Citation
Peng Z, Wei J, Wang F, Ying J, Deng Y, Gu K, Cheng Y, Yuan X, Xiao J, Tai Y, Wang L, Zou J, Zhang Y, Shen L. Camrelizumab Combined with Chemotherapy Followed by Camrelizumab plus Apatinib as First-line Therapy for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2021 Jun 1;27(11):3069-3078. doi: 10.1158/1078-0432.CCR-20-4691. Epub 2021 Mar 25.
Results Reference
derived
Learn more about this trial
A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer
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