A Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106)
NCT ID: NCT04675983
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
36 participants
INTERVENTIONAL
2021-03-10
2023-02-12
Brief Summary
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Detailed Description
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The primary endpoint of this study is OS of the ITT population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sintilimab + Ramucirumab
Ramucirumab on days 1 and 8 in combination with Sintilimab on day 1 of each 21-day cycle until disease progression, intolerable toxicity or other criteria for treatment discontinuation
Sintilimab
Administered IV
Ramucirumab
Administered IV
Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine
Cisplatin on day 1 in combination with 5-fluorouracil, continuous pumping for 24 hours a day on days 1 to 5 of each 21-day cycle. (FP regimen) or Oxaliplatin on day 1 in combination with capecitabine on days 1 to 14 of each 21-day cycle. (XELOX regimen)
Cisplatin
Administered IV
5-fluorouracil
Administered IV
Oxaliplatin
Administered IV
Capecitabine
Administered orally
Interventions
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Sintilimab
Administered IV
Ramucirumab
Administered IV
Cisplatin
Administered IV
5-fluorouracil
Administered IV
Oxaliplatin
Administered IV
Capecitabine
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, , China
Countries
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Other Identifiers
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CIBI308E302
Identifier Type: -
Identifier Source: org_study_id
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