Status:
TERMINATED
A Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106)
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Gastric Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 esophago...
Detailed Description
This is a randomized, multicenter, phase 3 study to evaluate the efficacy and safety of sintilimab combined with ramucirumab as compared to stand of care chemotherapy for the first-line treatment of P...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04675983
Start Date
March 10 2021
End Date
February 12 2023
Last Update
March 2 2023
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, China