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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03813784
Other study ID # SHR-1210-III-311
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 7, 2019
Est. completion date March 2023

Study information

Verified date August 2021
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by apatinib with or without SHR-1210 versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 887
Est. completion date March 2023
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or mestastatic 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 HER-2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled. - Has measurable disease per RECIST 1.1 - 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 known active central nervous system metastatases - Has received a live vaccine within 4 weeks prior to the first dose of study treatment - With any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, 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. - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor. - 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), orventricular arrhythmia which need medical intervention. - Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SHR-1210
Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
Capecitabine
1000 mg/m^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
Oxaliplatin
130 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle.
Apatinib
250 mg administered as continuous oral once daily (QD) of each 3-week cycle.

Locations

Country Name City State
China Beijing Cancer Hospital, Peking University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) of SHR-1210 in combination with capecitabine + oxaliplatin sequenced by SHR-1210+apatinib versus capecitabine + oxaliplatin in all subjects or programmed cell death ligand 1 (PD-L1) positive participants Up to 36 months after the first participant is randomized
Secondary Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Up to approximately 36 months
Secondary Progression-free Survival (PFS) per RECIST 1.1 Up to approximately 36 months
Secondary Number of Subjects with treatment-related adverse events (AEs) Up to approximately 36 months
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