Gastric Cancer, GastroEsophageal Cancer
Conditions
Keywords
PD-1, SHR-1210
Brief 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 SHR-1210 plus apatinib versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Interventions
DRUGSHR-1210
Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
DRUGCapecitabine
1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
DRUGOxaliplatin
130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.
DRUGApatinib
250 mg administered as continuous oral once daily (QD) of each 3-week cycle.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) per RECIST 1.1 | Up to approximately 36 months. |
| Incidence and severity of adverse events (AEs) | Up to approximately 36 months. |
| Incidence and severity of serious adverse events (SAEs) | Up to approximately 36 months. |
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to approximately 36 months. |
| Progression-free Survival (PFS) rates at 6 months | Up to approximately 6 months. |
| Disease Control Rate (DCR) per RECIST 1.1 | Up to approximately 36 months. |
| Duration of Response (DoR) per RECIST 1.1 | Up to approximately 36 months. |
| Overall survival (OS) rates at 12 months, 18 months and 24 months | Up to approximately 12 months, 18 months and 24 months. |
Countries
China
Outcome results
None listed