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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03813784
• Other study ID #: SHR-1210-III-311
• Status: Active, not recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Gastric Cancer
• GastroEsophageal Cancer
• Stomach Neoplasms

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