Phase 3 Trial Comparing SHR-A1912 Plus Rituximab, Gemcitabine, and Oxaliplatin with Standard R-GemOx Treatment in Adults with Relapsed or Refractory Diffuse Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating the efficacy of SHR-A1912 combined with Rituximab, Gemcitabine, and Oxaliplatin R-GemOx compared to R-GemOx alone in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. This phase 3, multicenter, randomized, open-label study aims to explore treatment outcomes in patients who have already undergone at least one prior systemic antitumor therapy. Participants will be randomly assigned to receive either the combination of SHR-A1912 with Rituximab, Gemcitabine, and Oxaliplatin or the standard R-GemOx treatment. These drugs are administered by injection, and the study compares these two treatment protocols to see if adding SHR-A1912 improves patient response. Treatment continues with monitoring over time according to the study schedule. During the study, participants will be regularly assessed for response to treatment and overall survival, with follow-up lasting up to five years after the first dose of the last enrolled patient. Researchers will also monitor adverse events throughout this period. The primary outcomes include complete response rate within one year and overall survival up to five years, allowing evaluation of both short- and long-term effects.

A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma