A Randomized, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Sintilimab Combined With Ramucirumab as Compared to Chemotherapy for the First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (ORIENT-106)

CIBI308E302

The main purpose of this study is to evaluate the efficacy and safety of sintilimab plus ramucirumab compared to stand of care first-line chemotherapy in participants with advanced gastric or esophagogastric adenocarcinoma.

2021-03-10

2023-02-12

2023-02-12

Terminated

Early phase I

36

Inclusion criteria * Have a histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma * With HER2 negative and PD-L1 positive tumor tissue * Have fresh or archival tumor tissue samples within 6 months for PD-L1 expression test. * Age ≥18 and ≤75 years * Diagnosed as unresectable locally advanced or metastatic stage Exclusion criteria * Have received any prior palliative systemic treatment for advanced gastric or gastroesophageal junction adenocarcinoma. * Known to have central nervous system metastases, cancerous meningitis, or bone metastases with a risk of paraplegia * Known bone metastasis with a risk of paraplegia. * Have any ascites that requires intervention. * With bilateral medium pleural effusion or unilateral large pleural effusion leading to respiratory symptoms

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

2023-03-02