The first-line treatment of diffuse large B-cell lymphoma with sintilimab combined R-CHOP regimen: a single-arm, single-center clinical trial

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900024299

Enrollment

Unknown

Registered

2019-07-05

Start date

2019-07-01

Completion date

Unknown

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse large B-cell lymphoma

Interventions

single arm:sintilimab combined with R-CHOP regimen

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed diffuse large b cell lymphoma; 2. Aged from 18 to 70 years; 3. Eastern Cancer Cooperation Group (ECOG) score 0-2; 4. Estimated time of survival more than 12 weeks; 5. Patient have at least one measurable lesions; 6. Adequate cardiopulmonary functione; 7. The Pregnancy test of blood or urine is negative for women of reproductive potential. All patients agree to use adequate methods of contraception during the treatment period and until >= 12 months after the last chemotherapy; 8. Ability and willingness to comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1. Patients who have received other checkpoint inhibitors, such as PD1 monoclonal antibody, pd-l1 monoclonal antibody and CTLA4 monoclonal antibody; 2. Patients who have received radiotherapy or chemotherapy for lymphoma; 3. Operations were performed within 3 weeks after the study; 4. Previous medical history of other malignant tumors; 5. Females of childbearing age with recent family planning; 6. With active infection; 7. Suspected human immunodeficiency virus (HIV)/AIDS; 8. Difficult to control or severe cardiovascular diseases; 9. Possible allergy, allergy or intolerance to research drugs; 10. Patients with interstitial lung disease; 11. Severe diseases that may interfere with research; 12. Patients received another research drug at the same time. 13. According to the judgement of the researcher, there are other unsuitable situations for the patients to be enrolled in the group.

Design outcomes

Primary

Measure	Time frame
Overall response rate;	—

Secondary

Measure	Time frame
Duration of Response;Progression Free Survival;Overall Survival;Adverse events;	—

Countries

China

Contacts

Public ContactJunmin Chen

The First Affiliated Hospital of Fujian Medical University

drjunminchen@hotmail.com+86 13489036064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026