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First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study

First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057623
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-02-28
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

DLBCL

Interventions

Group A:Sintilimab + R-CHOP
Group B:R-CHOP

Sponsors

The Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years, = 3 months.

Exclusion criteria

Exclusion criteria: 1. Suffering from other uncured malignant tumors; 2. Uncontrolled of cardiovascular disease that is still unstable; 3. Suffering from severe interstitial lung disease; 4. Cognitive dysfunction; 5. Uncontrolled autoimmune diseases; 6. Uncontrolled active infection; 7. Lactating women and subjects of childbearing age who do not agree with contraception; 8. Poor compliance or inability to follow visitors regularly.

Design outcomes

Primary

MeasureTime frame
complete response rate;

Secondary

MeasureTime frame
Progression Free Survival in first year;objective response rate;

Countries

China

Contacts

Public ContactXiuhua Sun

The Second Affiliated Hospital of Dalian Medical University

sxh17709873631@163.com+86 17709873631

Outcome results

None listed

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