Beijing Cancer Hospital, Peking University
Beijing, Beijing Municipality, China
NCT Number: NCT03813784
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
1000 mg/m^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
130 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle.
250 mg administered as continuous oral once daily (QD) of each 3-week cycle.
Time frame: Up to 36 months after the first participant is randomized.
Time frame: Up to approximately 36 months.
Time frame: Up to approximately 36 months.
Time frame: Up to approximately 36 months.
Time frame: Up to approximately 36 months.
Time frame: Up to approximately 12 months, 18 months and 24 months.
Time frame: Up to approximately 6 months.
Time frame: Up to approximately 36 months.
Time frame: Up to approximately 36 months.
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Randomized, Open-label, Multi-center Phase III Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic Therapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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