Clinical trial · Interventional
A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma
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
NCT06929624CI-TRIAL-00116434active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine | ALIAS |
| Oxaliplatin Injection | Drug | Oxaliplatin | ALIAS |
| Rituximab Injection | Drug | Rituximab | ALIAS |
| SHR-A1912 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin
- interventionNames
- Drug: SHR-A1912 Injection
- Drug: Rituximab Injection
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Oxaliplatin Injection
- type
- ACTIVE_COMPARATOR
- label
- Rituximab + Gemcitabine + Oxaliplatin
- interventionNames
- Drug: Rituximab Injection
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Oxaliplatin Injection
Primary outcomes (2)
- measure
- Complete response rate (CRR)
- timeFrame
- Up to 1 years following the first dose of the last enrolled patient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.