Back to resultsStudy to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
camrelizumab
Apatinib Mesylate
Paclitaxel
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
- Confirmed metastatic or locally advanced, unresectable disease.
- Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
- Willing to provide tumor tissue for PD-L1 biomarker analysis.
- Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- Signing the informed consent forms.
- Adequate bone marrow, liver and renal function.
Exclusion Criteria:
- Squamous cell or undifferentiated gastric cancer.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
- Clinically significant cardiovascular and cerebrovascular diseases.
- Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
- Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
- Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
- Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
- Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
Sites / Locations
- Affiliated Hospital, Academy of Military Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
camrelizumab (SHR-1210) combined with apatinib
Paclitaxel or Irinotecan
Arm Description
Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.
Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle.
Outcomes
Primary Outcome Measures
Overall Survival (OS) in PD-L1 Positive Participants.
OS was defined as the time from randomization to death due to any cause.
Secondary Outcome Measures
Overall Survival (OS) in All Participants.
OS was defined as the time from randomization to death due to any cause.
Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants.
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants.
Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants
TTF was defined as the time from randomization to treatment discontinuation caused by any reason.
Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.
Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants.
DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.
Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
TTR was defined as the time from randomization to the first documented evidence of CR or PR.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Serum concentration of camrelizumab
Serum concentration of camrelizumab
Plasma concentration of apatinib
plasma concentration of apatinib
Full Information
NCT ID
NCT04342910
First Posted
April 9, 2020
Last Updated
February 20, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04342910
Brief Title
Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
Official Title
A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (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
5. Study Description
Brief Summary
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
camrelizumab (SHR-1210) combined with apatinib
Arm Type
Experimental
Arm Description
Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.
Arm Title
Paclitaxel or Irinotecan
Arm Type
Active Comparator
Arm Description
Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
camrelizumab
Other Intervention Name(s)
SHR-1210
Intervention Description
200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Apatinib Mesylate
Intervention Description
250 mg qd
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
180 mg/m^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.
Primary Outcome Measure Information:
Title
Overall Survival (OS) in PD-L1 Positive Participants.
Description
OS was defined as the time from randomization to death due to any cause.
Time Frame
Up to 27 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in All Participants.
Description
OS was defined as the time from randomization to death due to any cause.
Time Frame
Up to 27 months
Title
Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants.
Description
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
Time Frame
Up to 27 months
Title
Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
Description
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants.
Time Frame
Up to 27 months
Title
Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants
Description
TTF was defined as the time from randomization to treatment discontinuation caused by any reason.
Time Frame
Up to 27 months
Title
Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
Description
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.
Time Frame
Up to 27 months
Title
Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants.
Description
DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to 27 months
Title
Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
Description
DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.
Time Frame
Up to 27 months
Title
Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
Description
TTR was defined as the time from randomization to the first documented evidence of CR or PR.
Time Frame
Up to 27 months
Title
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
Description
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
Time Frame
Up to 27 months
Title
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Description
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Time Frame
Up to 27 months
Title
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Description
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Time Frame
Up to 27 months
Title
Serum concentration of camrelizumab
Description
Serum concentration of camrelizumab
Time Frame
Up to 27 months
Title
Plasma concentration of apatinib
Description
plasma concentration of apatinib
Time Frame
Up to 27 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
Confirmed metastatic or locally advanced, unresectable disease.
Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
Willing to provide tumor tissue for PD-L1 biomarker analysis.
Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.
ECOG performance status of 0 to 1.
Life expectancy of more than 12 weeks.
Signing the informed consent forms.
Adequate bone marrow, liver and renal function.
Exclusion Criteria:
Squamous cell or undifferentiated gastric cancer.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
Clinically significant cardiovascular and cerebrovascular diseases.
Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanren Wang, Ph.D
Phone
+862161053363
Email
wangquanren@hrglobe.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, Ph.D
Organizational Affiliation
Affiliated Hospital, Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital, Academy of Military Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, PhD
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
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