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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Central nervous system lymphoma involvement.

Primary mediastinal (thymus) large B-cell lymphoma.

Patients who have only one prior line therapy and are candidates for stem cell transplantation.

A history of immunodeficiency.

Trial design

Treatments tested in this trial

  • SHR-A1912 Injection
  • Rituximab Injection
  • Gemcitabine Hydrochloride for Injection
  • Oxaliplatin Injection

Treatment groups

280 Participants
are divided into 2 treatment groups