A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
• Have received ≥1 line of systemic antitumor therapy.
• At least one bi-dimensionally measurable lesion.
• Expected survival of at least 3 months.
• Age ≥18 years old and under 80 years old.
• The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Mengbo Zhao
mengbo.zhao@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2028-01
Participants
Target number of participants: 280
Treatments
Experimental: SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
Active_comparator: Rituximab + Gemcitabine + Oxaliplatin
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.