Study of IBI363 in Patients with Advanced First-line Gastric Cancer
NCT ID: NCT06610799
Last Updated: 2024-11-20
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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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2024-10-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma
IBI363
IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W
Interventions
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IBI363
IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W
Eligibility Criteria
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Inclusion Criteria
2. Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
3. Subjects with at least one measurable lesion according to RECIST v1.1.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
5. Expected survival time ≥ 3 months.
Exclusion Criteria
2. Active uncontrolled bleeding or a known bleeding diathesis.
3. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
18 Years
75 Years
ALL
No
Sponsors
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Xiangdong Cheng
OTHER
Responsible Party
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Xiangdong Cheng
Secretary of the party committee
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIBI363Y110
Identifier Type: -
Identifier Source: org_study_id
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