Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2+ Gastric Cancer
HER2+ Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
About this trial
This is an interventional treatment trial for HER2+ Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Age from 18 to 75 , Male and female participants Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction; HER2 positive; Phase Ib: progression at least one prior Regimen or could not tolerate the standard treatment,pevious anti-HER2 therapy was included Phase II: previously untreated patients ; ECOG 0-1; The expected survival ≥3 months; Sufficient bone marrow and organ functions; Exclusion Criteria: There were ascites, pleural effusion and pericardial effusion that needed to be treated; Major surgery was performed within 4 weeks; Have active autoimmune disease or history of autoimmune disease; Patients with interstitial pneumonia; There was severe infection within 4 weeks before starting the study treatment; Patients with active pulmonary tuberculosis infection history within 1 year before enrollment; Serious cardiovascular and cerebrovascular diseases; Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
Sites / Locations
- Zhongshan Hospital, FuDan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm 1A: SHR-A1811 and SHR-1701
Arm 1B: SHR-A1811 and capecitabine
Arm 1C: SHR-A181,SHR-1701,and capecitabine
Arm 1D: SHR-A1811,capecitabine,and oxaliplatin
Arm 2A: SHR-A1811 and SHR-1701
Arm 2B: SHR-A181,SHR-1701,and capecitabine
Arm 2C: SHR-A1811,capecitabine,and oxaliplatin