Gemcitabine Hydrochloride for Injection: Gemcitabine hydrochloride for injection.
Oxaliplatin Injection: Oxaliplatin injection.
Study summary
This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
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:
1. Central nervous system lymphoma involvement.
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.
Primary outcome measure(s)
Complete response rate (CRR) — Up to 1 years following the first dose of the last enrolled patient.
Overall survival (OS) — Up to 5 years following the first dose of the last enrolled patient.
Trial sites (2)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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