Clinical trial NCT03813784: A Study to Evaluate SHR-1210 in Combination With Capecitabine + Oxaliplatin Sequenced by SHR-1210 + Apatinib as First-line Therapy in Treatment of Advanced Gastric Cancer
Official title: A Randomized, Multicenter, Open-Label, Phase 3 Study Comparing the Efficacy and Safety of SHR-1210 Plus Capecitabine and Oxaliplatin Sequenced by Apatinib With or Without SHR-1210 Versus Capecitabine and Oxaliplatin in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
GastroEsophageal Cancer
Keywords: PD-1
SHR-1210
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 885
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 36 months after the first participant is randomized
Secondary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: Up to approximately 36 months
measure: Progression-free Survival (PFS) per RECIST 1.1
timeFrame: Up to approximately 36 months
measure: Number of Subjects with treatment-related adverse events (AEs)
timeFrame: Up to approximately 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital, Peking University
state: Beijing
Study officials:
References: