A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma
NCT ID: NCT06929624
Last Updated: 2025-11-18
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
PHASE3
280 participants
INTERVENTIONAL
2025-04-24
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
SHR-A1912 Injection
SHR-A1912 injection.
Rituximab Injection
Rituximab injection.
Gemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection.
Oxaliplatin Injection
Oxaliplatin injection.
Rituximab + Gemcitabine + Oxaliplatin
Rituximab Injection
Rituximab injection.
Gemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection.
Oxaliplatin Injection
Oxaliplatin injection.
Interventions
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SHR-A1912 Injection
SHR-A1912 injection.
Rituximab Injection
Rituximab injection.
Gemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection.
Oxaliplatin Injection
Oxaliplatin injection.
Eligibility Criteria
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Inclusion Criteria
2. Have received ≥1 line of systemic antitumor therapy.
3. At least one bi-dimensionally measurable lesion.
4. Expected survival of at least 3 months.
5. Age ≥18 years old and under 80 years old.
6. The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.
Exclusion Criteria
2. Primary mediastinal (thymus) large B-cell lymphoma.
3. Patients who have only one prior line therapy and are candidates for stem cell transplantation.
4. A history of immunodeficiency.
5. A history of severe cardiovascular disease.
6. A history of other malignancies within 5 years prior to administration of the first dose.
18 Years
80 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-A1912-301
Identifier Type: -
Identifier Source: org_study_id
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